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A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00536471
Collaborator
(none)
776
Enrollment
47
Locations
2
Arms
15
Duration (Months)
16.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.

Condition or Disease Intervention/Treatment Phase
  • Drug: Duloxetine hydrochloride
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
776 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

duloxetine 60 milligrams (mg) every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months

Drug: Duloxetine hydrochloride
Other Names:
  • LY248686
  • Cymbalta

    		•
    Placebo Comparator: B

    placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) [baseline, 8 weeks]

      Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).

    Secondary Outcome Measures

    1. Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) [Baseline, 8 weeks, 12 weeks, 9 months]

      The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.

    2. Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score [Baseline, 12 weeks, 9 months]

    3. Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood [Baseline, 12 weeks, 9 months]

      Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).

    4. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt [Baseline, 12 weeks, 9 months]

      Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).

    5. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide [Baseline, 12 weeks, 9 Months]

      Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).

    6. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early [Baseline, 12 weeks, 9 months]

      Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).

    7. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle [Baseline, 12 weeks, 9 months]

      Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).

    8. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late [Baseline, 12 weeks, 9 months]

      Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).

    9. Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities [Baseline, 9 months]

      Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).

    10. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation [Baseline, 12 weeks, 9 months]

      Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).

    11. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation [Baseline, 12 weeks, 9 months]

      Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)

    12. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) [Baseline, 12 weeks, 9 months]

      Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)

    13. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) [Baseline, 12 weeks, 9 months]

      Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).

    14. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal [Baseline, 12 weeks, 9 months]

      Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).

    15. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General [Baseline, 12 weeks, 9 months]

      Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).

    16. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms [Baseline, 12 weeks, 9 months]

      Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).

    17. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis [Baseline, 12 weeks, 9 months]

      Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).

    18. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight [Baseline, 12 weeks, 9 months]

      Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).

    19. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight [Baseline, 12 weeks, 9 months]

      Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).

    20. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation [Baseline, 12 weeks, 9 months]

      Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).

    21. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity [Baseline, 12 weeks, 9 months]

      Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).

    22. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization [Baseline, 12 weeks, 9 months]

      Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).

    23. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms [Baseline, 12 weeks, 9 months]

      Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).

    24. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms [Baseline, 12 weeks, 9 months]

      Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).

    25. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness [Baseline, 12 weeks, 9 months]

      Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).

    26. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness [Baseline, 12 weeks, 9 months]

      Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).

    27. Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness [Baseline, 12 weeks, 9 months]

      Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).

    28. Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). [Baseline, 12 weeks]

      The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).

    29. Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) [Baseline, 9 months]

      The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).

    30. Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [Baseline, 12 weeks]

      The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.

    31. Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores [Baseline, 9 months]

      The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.

    32. Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 [Over 12 weeks]

      Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.

    33. Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect [over 12 weeks]

      For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

    34. Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score [over 12 weeks]

      Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.

    35. Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect [Over 12 weeks]

      For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.

    36. Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score [Baseline, 12 weeks, 9 months]

      A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.

    37. Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint [12 weeks, 9 months]

      Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.

    38. Probability of Response at 12 Week Endpoint [12 weeks]

      Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.

    39. Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) [Baseline, 12 weeks, 9 months]

      Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).

    40. Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [Baseline, 12 weeks, 9 months]

      Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

    41. Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) [Baseline, 12 weeks, 9 months]

      A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.

    42. Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score [Baseline, 12 weeks, 9 months]

      A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.

    43. Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure [Baseline, 12 weeks, 9 months]

      Sitting systolic and diastolic blood pressure.

    44. Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate [Baseline, 12 weeks, 9 months]

    45. Change From Baseline to 12 Week and 9 Month Endpoints in Weight [Baseline, 12 weeks, 9 months]

    46. Abnormal Vital Signs at Anytime Over 12 Weeks [over 12 weeks]

    47. Abnormal Vital Signs at Anytime Over 9 Months [over 9 months]

    48. Abnormal Vital Signs at 12 Week Endpoint [12 weeks]

    49. Abnormal Vital Signs at 9 Month Endpoint [9 months]

    50. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid [Baseline, 12 weeks, 9 months]

    51. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit [Baseline, 12 weeks, 9 months]

    52. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) [Baseline, 12 weeks, 9 months]

    53. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium [Baseline, 12 weeks, 9 months]

    54. Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count [Baseline, 12 weeks, 9 months]

    55. Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase [baseline, 9 months]

    56. Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin [Baseline, 9 months]

    57. Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint [over 3 months]

      The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.

    58. Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months [over 9 months]

    59. Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint [9 months]

    60. Summary of Adverse Events Leading to Discontinuation [over 9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female outpatients

    • Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)

    • Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2

    • Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2

    • Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

    Exclusion Criteria:

    • Patients judged clinically to be at serious suicidal risk in the opinion of the investigator

    • Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia

    • Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD

    • Patients with uncontrolled narrow-angle glaucoma

    • Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beverly Hills California United States 90210
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Escondido California United States 92025
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. National City California United States 91950
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamden Connecticut United States 06518
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Britain Connecticut United States 06050
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New London Connecticut United States 06320
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wilmington Delaware United States 19808
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Washington District of Columbia United States 20037
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bradenton Florida United States 34208
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Myers Florida United States 33912
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gainesville Florida United States 32606
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Maitland Florida United States 32751
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Atlanta Georgia United States 30328
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edwardsville Illinois United States 62025
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hoffman Estates Illinois United States 60169
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Naperville Illinois United States 60540
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oak Brook Illinois United States 60523
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lafayette Indiana United States 47905
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Terre Haute Indiana United States 47802
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prairie Village Kansas United States 66206
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baltimore Maryland United States 21285
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Glen Burnie Maryland United States 21061
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rockville Maryland United States 20852
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belmont Massachusetts United States 02478
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pittsfield Massachusetts United States 01201
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chesterfield Missouri United States 63017
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Louis Missouri United States 63141
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St. Peters Missouri United States 63376
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Clementon New Jersey United States 08021
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cedarhurst New York United States 11516
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10021
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Olean New York United States 14760
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Staten Island New York United States 10305
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Allentown Pennsylvania United States 18104
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Media Pennsylvania United States 19063
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Philadelphia Pennsylvania United States 19104
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38119
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lake Jackson Texas United States 77566
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arlington Virginia United States 22201
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charlottesville Virginia United States 22903
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Richmond Virginia United States 23230
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brown Deer Wisconsin United States 53223
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. West Allis Wisconsin United States 53227
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arecibo Puerto Rico 00612
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    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ponce Puerto Rico 00731
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Juan Puerto Rico 00907

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00536471
    Other Study ID Numbers:
    • 11669
    • F1J-US-HMFS
    First Posted:
    Sep 27, 2007
    Last Update Posted:
    Nov 20, 2009
    Last Verified:
    Nov 1, 2009
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Duloxetine Hydrochloride

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Study HMFS comprises two identical trials (identified as Group A and Group B). Study Period I was a screening period. Study Period II was a 9-month double-blind treatment period. Study Period III was an optional double-blind 2-week discontinuation/taper period.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Period Title: Overall Study
    STARTED 257 127 261 131
    COMPLETED 101 43 122 57
    NOT COMPLETED 156 84 139 74

    Baseline Characteristics

    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo Total
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). Total of all reporting groups
    Overall Participants 257 127 261 131 776
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.2
    (12.2)
    43.7
    (12.5)
    44.7
    (12.2)
    43.9
    (11.9)
    43.6
    (12.2)
    Sex: Female, Male (Count of Participants)
    Female
    155
    60.3%
    78
    61.4%
    169
    64.8%
    87
    66.4%
    489
    63%
    Male
    102
    39.7%
    49
    38.6%
    92
    35.2%
    44
    33.6%
    287
    37%
    Region of Enrollment (participants) [Number]
    United States
    249
    96.9%
    123
    96.9%
    222
    85.1%
    110
    84%
    704
    90.7%
    Puerto Rico
    8
    3.1%
    4
    3.1%
    39
    14.9%
    21
    16%
    72
    9.3%
    History - Atypical Depression (participants) [Number]
    Yes
    7
    2.7%
    5
    3.9%
    19
    7.3%
    7
    5.3%
    38
    4.9%
    No
    250
    97.3%
    122
    96.1%
    242
    92.7%
    124
    94.7%
    738
    95.1%
    History - Melancholic Depression (participants) [Number]
    Yes
    134
    52.1%
    71
    55.9%
    147
    56.3%
    71
    54.2%
    423
    54.5%
    No
    123
    47.9%
    56
    44.1%
    114
    43.7%
    60
    45.8%
    353
    45.5%
    History - Seasonal Pattern in Major Depressive Disorder (MDD) if ≥3 Previous MDD Episodes (participants) [Number]
    Yes
    3
    1.2%
    3
    2.4%
    9
    3.4%
    4
    3.1%
    19
    2.4%
    No
    220
    85.6%
    105
    82.7%
    232
    88.9%
    112
    85.5%
    669
    86.2%
    Missing Response
    34
    13.2%
    19
    15%
    20
    7.7%
    15
    11.5%
    88
    11.3%
    Race/Ethnicity (participants) [Number]
    African
    63
    24.5%
    36
    28.3%
    30
    11.5%
    16
    12.2%
    145
    18.7%
    Caucasian
    160
    62.3%
    73
    57.5%
    172
    65.9%
    81
    61.8%
    486
    62.6%
    Hispanic
    29
    11.3%
    11
    8.7%
    55
    21.1%
    30
    22.9%
    125
    16.1%
    East Asian
    3
    1.2%
    5
    3.9%
    3
    1.1%
    1
    0.8%
    12
    1.5%
    West Asian (Indian sub-continent)
    2
    0.8%
    2
    1.6%
    1
    0.4%
    2
    1.5%
    7
    0.9%
    Native American
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    1
    0.1%
    Body Height (centimeters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeters]
    168.1
    (10.1)
    168.5
    (9.2)
    169.0
    (9.7)
    168.8
    (9.4)
    168.6
    (9.7)
    Body Weight (kilograms) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms]
    88.8
    (23.7)
    84.9
    (22.5)
    88.6
    (26.6)
    86.4
    (23.5)
    87.7
    (24.5)
    Evaluation - Brief Profile of Mood States (BPOMS) (units on a scale) [Mean (Standard Deviation) ]
    Total Score
    49.0
    (19.2)
    47.5
    (18.7)
    51.8
    (19.3)
    51.8
    (18.7)
    50.2
    (19.1)
    Tension-Anxiety Score
    9.5
    (4.6)
    9.2
    (4.6)
    10.0
    (5.0)
    10.4
    (4.6)
    9.8
    (4.7)
    Depression-Dejection Score
    11.8
    (4.8)
    11.5
    (4.8)
    12.3
    (4.6)
    12.0
    (4.2)
    12.0
    (4.7)
    Anger-Hostility Score
    8.9
    (5.4)
    9.0
    (5.4)
    9.5
    (5.1)
    9.5
    (5.4)
    9.2
    (5.3)
    Vigor-Activity Score
    3.4
    (3.1)
    3.9
    (3.1)
    3.6
    (3.5)
    3.4
    (3.0)
    3.5
    (3.2)
    Fatigue-Inertia Score
    12.8
    (4.6)
    12.3
    (4.8)
    13.5
    (4.7)
    13.2
    (4.5)
    13.0
    (4.7)
    Confusion-Bewilderment Score
    9.7
    (4.0)
    9.6
    (3.9)
    9.8
    (4.1)
    10.1
    (3.8)
    9.8
    (4.0)
    Evaluation - 16-Item Quick Inventory of Depressive Symptomatology (QIDS16) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    14.7
    (4.1)
    13.7
    (4.4)
    15.0
    (4.4)
    14.7
    (3.8)
    14.6
    (4.2)
    Evaluation - 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    22.9
    (4.3)
    22.8
    (3.7)
    22.8
    (4.5)
    22.9
    (4.9)
    22.8
    (4.4)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 10:Anxiety (Psychic) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    2.1
    (0.8)
    2.1
    (0.7)
    2.1
    (0.8)
    2.2
    (0.8)
    2.1
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 11:Anxiety (Somatic) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.4
    (0.8)
    1.5
    (0.8)
    1.6
    (0.9)
    1.6
    (0.9)
    1.5
    (0.9)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 13:Somatic Symptoms/General (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.6
    (0.6)
    1.7
    (0.5)
    1.7
    (0.5)
    1.7
    (0.6)
    1.7
    (0.5)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 14:Genital Symptoms (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.3
    (0.8)
    1.2
    (0.9)
    1.3
    (0.8)
    1.1
    (0.9)
    1.2
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 15:Hypochondriasis (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.7
    (0.8)
    0.7
    (0.8)
    1.0
    (0.9)
    1.1
    (0.9)
    0.9
    (0.9)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 16:Loss of Weight (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.3
    (0.6)
    0.2
    (0.5)
    0.3
    (0.6)
    0.4
    (0.7)
    0.3
    (0.6)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 17:Insight (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.2
    (0.4)
    0.2
    (0.4)
    0.1
    (0.2)
    0.0
    (0.2)
    0.1
    (0.4)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 18A:Diurnal Variation (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.8
    (0.8)
    0.9
    (0.9)
    1.0
    (0.9)
    1.0
    (0.9)
    0.9
    (0.9)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 1:Depressed Mood (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    3.0
    (0.6)
    2.9
    (0.6)
    2.9
    (0.6)
    2.9
    (0.5)
    2.9
    (0.6)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 20:Paranoid Symptoms (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.2
    (0.5)
    0.2
    (0.5)
    0.2
    (0.5)
    0.2
    (0.4)
    0.2
    (0.5)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 22B:Helplessness (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.4
    (1.0)
    1.5
    (1.0)
    1.5
    (1.0)
    1.7
    (1.0)
    1.5
    (1.0)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 23B:Hopelessness (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.3
    (0.8)
    1.3
    (0.9)
    1.3
    (0.8)
    1.3
    (0.9)
    1.3
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 24B:Worthlessness (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.5
    (1.0)
    1.5
    (1.0)
    1.6
    (1.1)
    1.6
    (1.1)
    1.5
    (1.0)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 2:Feelings of Guilt (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.8
    (0.7)
    2.0
    (0.7)
    1.8
    (0.6)
    1.7
    (0.8)
    1.8
    (0.7)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 3:Suicide (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.6
    (0.7)
    0.7
    (0.7)
    0.6
    (0.8)
    0.6
    (0.8)
    0.6
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 4:Insomnia Early (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.5
    (0.8)
    1.4
    (0.8)
    1.4
    (0.8)
    1.4
    (0.8)
    1.4
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 5:Insomnia Middle (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.5
    (0.7)
    1.5
    (0.6)
    1.4
    (0.8)
    1.5
    (0.7)
    1.5
    (0.7)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 6:Insomnia Late (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.2
    (0.8)
    1.3
    (0.8)
    1.1
    (0.8)
    1.1
    (0.8)
    1.2
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 7:Work and Activities (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    2.9
    (0.5)
    2.8
    (0.6)
    2.8
    (0.5)
    2.8
    (0.5)
    2.8
    (0.5)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 8:Retardation (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.1
    (0.7)
    1.0
    (0.7)
    1.1
    (0.8)
    1.1
    (0.9)
    1.1
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 9:Agitation (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.9
    (0.9)
    0.9
    (0.8)
    0.9
    (0.9)
    1.0
    (0.9)
    0.9
    (0.9)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Anxiety/Somatization Subscale Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    6.8
    (2.1)
    6.9
    (1.9)
    7.1
    (2.3)
    7.3
    (2.4)
    7.0
    (2.2)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Bech Subscale Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    12.6
    (2.0)
    12.5
    (1.7)
    12.4
    (1.9)
    12.3
    (2.2)
    12.5
    (2.0)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Maier Subscale Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    11.8
    (2.2)
    11.7
    (1.9)
    11.6
    (2.2)
    11.6
    (2.4)
    11.7
    (2.2)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Retardation Subscale Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    8.2
    (1.6)
    8.0
    (1.6)
    8.0
    (1.6)
    7.9
    (1.6)
    8.1
    (1.6)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Sleep Subscale Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.2
    (1.6)
    4.3
    (1.5)
    3.9
    (1.7)
    4.0
    (1.5)
    4.1
    (1.6)
    Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    28.6
    (6.0)
    28.6
    (5.5)
    28.7
    (6.2)
    29.0
    (6.7)
    28.7
    (6.1)
    Evaluation - 24-Item Hamilton Depression Rating Scale - Item 12:Somatic Symptoms/Gastrointestinal (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.7
    (0.7)
    0.6
    (0.7)
    0.6
    (0.7)
    0.7
    (0.7)
    0.7
    (0.7)
    Evaluation - 24-Item Hamilton Depression Rating Scale - Item 18B:Diurnal Variation-Severity (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.8
    (0.8)
    0.9
    (0.9)
    0.9
    (0.8)
    1.0
    (0.9)
    0.9
    (0.8)
    Evaluation - 24-Item Hamilton Depression Rating Scale - Item 19: Depersonalization and Derealization (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.2
    (0.6)
    0.3
    (0.6)
    0.2
    (0.5)
    0.2
    (0.5)
    0.2
    (0.6)
    Evaluation - 24-Item Hamilton Depression Rating Scale - Item 21:Obsessional and Compulsive Symptoms (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.1
    (0.4)
    0.1
    (0.4)
    0.1
    (0.4)
    0.1
    (0.4)
    0.1
    (0.4)
    Evaluation - Clinical Global Impressions of Severity Scale (CGI-S) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.6
    (0.6)
    4.5
    (0.6)
    4.7
    (0.7)
    4.7
    (0.7)
    4.6
    (0.7)
    Evaluation - Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    28.4
    (6.0)
    26.8
    (6.1)
    28.6
    (6.1)
    28.6
    (5.4)
    28.2
    (6.0)
    Evaluation - Pain Numerical Rating Scale (NRS) Score Item 1 (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.3
    (2.8)
    4.1
    (2.7)
    4.5
    (3.1)
    4.5
    (2.8)
    4.4
    (2.9)
    Evaluation - Pain Numerical Rating Scale (NRS) Score Item 7 (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.7
    (3.0)
    4.5
    (3.1)
    4.7
    (3.2)
    4.9
    (3.2)
    4.7
    (3.1)
    Evaluation - Sheehan Disability Scale (SDS) Item 1 (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    5.5
    (2.8)
    5.4
    (2.7)
    5.6
    (2.7)
    5.3
    (2.8)
    5.5
    (2.7)
    Evaluation - Sheehan Disability Scale (SDS) Item 2 (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    6.6
    (2.4)
    6.2
    (2.8)
    6.4
    (2.8)
    5.9
    (2.5)
    6.3
    (2.6)
    Evaluation - Sheehan Disability Scale (SDS) Item 3 (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    6.5
    (2.5)
    6.0
    (2.6)
    6.2
    (2.6)
    6.0
    (2.5)
    6.2
    (2.6)
    Evaluation - Sheehan Disability Scale (SDS) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    19.0
    (6.5)
    17.8
    (7.3)
    18.4
    (7.1)
    17.5
    (7.0)
    18.3
    (6.9)
    Evaluation - Social Adaptation Self-Evaluation Scale (SASS) Total (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    27.2
    (7.3)
    29.1
    (8.4)
    27.6
    (8.2)
    29.3
    (8.2)
    28.0
    (8.0)
    History - Age at First Episode (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.0
    (13.2)
    31.2
    (13.7)
    30.7
    (13.6)
    30.0
    (12.6)
    30.4
    (13.3)
    History - How Long was Last Major Depressive Disorder (MDD) Episode (weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [weeks]
    4.7
    (6.3)
    5.0
    (7.4)
    5.2
    (6.9)
    6.5
    (14.5)
    5.2
    (8.6)
    History - Interval Between Start of Current and Remission of Last MDD Episode (weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [weeks]
    13.2
    (20.1)
    12.5
    (24.3)
    13.1
    (22.1)
    13.1
    (22.2)
    13.0
    (21.8)
    History - Number of Previous Episodes (number of previous episodes) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of previous episodes]
    4.0
    (4.8)
    3.8
    (4.3)
    4.9
    (5.4)
    5.2
    (5.4)
    4.5
    (5.1)
    History - Time Since First Episode Date (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    12.3
    (11.6)
    12.5
    (11.6)
    14.0
    (11.5)
    14.0
    (12.0)
    13.2
    (11.7)
    History - Time Since Most Recent Episode (weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [weeks]
    44.0
    (60.2)
    48.8
    (69.5)
    51.4
    (103.3)
    59.2
    (111.2)
    49.8
    (87.3)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)
    Description Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
    Time Frame baseline, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 214 102 220 110
    Least Squares Mean (Standard Error) [units on a scale]
    -1.32
    (0.07)
    -1.07
    (0.11)
    -1.37
    (0.07)
    -0.93
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.
    Method Mixed Models Analysis
    Comments Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.
    Method Mixed Models Analysis
    Comments Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    2. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)
    Description The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.
    Time Frame Baseline, 8 weeks, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 214 102 220 110
    Total Score 12 Week Change (n=194,n=59,n=195,n=64)
    -12.64
    (0.50)
    -10.33
    (0.79)
    -12.11
    (0.47)
    -8.48
    (0.75)
    Maier 8 Week Change (n=214,n=102,n=220,n=110)
    -6.11
    (0.27)
    -4.69
    (0.38)
    -6.13
    (0.24)
    -4.45
    (0.33)
    Anxiety 12 Week Change (n=194,n=59,n=195,n=64)
    -3.52
    (0.16)
    -3.12
    (0.27)
    -3.52
    (0.17)
    -2.44
    (0.27)
    Bech 12 Week Change (n=194,n=59,n=195,n=64)
    -7.38
    (0.29)
    -6.17
    (0.47)
    -6.98
    (0.27)
    -4.70
    (0.43)
    Retardation 12 Week Change (n=194,n=59,n=195,n=64)
    -4.72
    (0.19)
    -4.06
    (0.32)
    -4.49
    (0.19)
    -3.05
    (0.31)
    Sleep 12 Week Change (n=194,n=59,n=195,n=64)
    -2.08
    (0.13)
    -1.72
    (0.22)
    -1.91
    (0.12)
    -1.48
    (0.20)
    Total Score 9 Month Change (n=29,n=9,n=33,n=10)
    -14.38
    (1.02)
    -13.38
    (1.86)
    -9.56
    (1.26)
    -5.92
    (2.32)
    Anxiety 9 Month Change (n=29,n=9,n=33,n=10)
    -4.09
    (0.30)
    -3.88
    (0.56)
    -3.44
    (0.35)
    -2.77
    (0.65)
    Bech 9 Month Change (n=29,n=9,n=33,n=10)
    -8.56
    (0.58)
    -8.02
    (1.04)
    -5.80
    (0.70)
    -4.35
    (1.30)
    Retardation 9 Month Change (n=29,n=9,n=33,n=10)
    -5.35
    (0.40)
    -5.83
    (0.72)
    -3.68
    (0.44)
    -2.52
    (0.81)
    Sleep 9 Month Change (n=29,n=9,n=33,n=10)
    -2.77
    (0.23)
    -2.56
    (0.40)
    -2.55
    (0.26)
    -1.95
    (0.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.026
    Comments P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.202
    Comments P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.076
    Comments P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.149
    Comments P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.062
    Comments P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.629
    Comments P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.194
    Comments P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.525
    Comments P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.595
    Comments P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.736
    Comments P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.368
    Comments P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.660
    Comments P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.334
    Comments P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.568
    Comments P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.216
    Comments P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.646
    Comments P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.275
    Comments P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
    Method Mixed Models Analysis
    Comments
    3. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 193 57 194 64
    12 Week Change
    -16.24
    (0.62)
    -13.24
    (1.01)
    -15.60
    (0.61)
    -10.94
    (0.96)
    9 Month Change (n=29, n=8, n=32, n=10)
    -17.05
    (1.15)
    -15.22
    (2.14)
    -13.49
    (1.45)
    -9.12
    (2.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline)
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.449
    Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.167
    Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    4. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood
    Description Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -1.86
    (0.07)
    -1.52
    (0.12)
    -1.78
    (0.07)
    -1.15
    (0.12)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.44
    (0.20)
    -1.26
    (0.34)
    -1.98
    (0.19)
    -1.65
    (0.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.653
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.417
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    5. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt
    Description Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -1.19
    (0.06)
    -1.06
    (0.09)
    -1.15
    (0.05)
    -0.89
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.32
    (0.10)
    -1.21
    (0.17)
    -1.37
    (0.06)
    -1.16
    (0.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.204
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.571
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.133
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    6. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide
    Description Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).
    Time Frame Baseline, 12 weeks, 9 Months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.46
    (0.04)
    -0.30
    (0.06)
    -0.40
    (0.04)
    -0.29
    (0.06)
    9 Month Change (n=29, n= 9, n=33, n=10)
    -1.32
    (0.10)
    -1.21
    (0.17)
    -1.37
    (0.06)
    -1.16
    (0.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.100
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.571
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.133
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    7. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early
    Description Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.72
    (0.06)
    -0.61
    (0.10)
    -0.68
    (0.06)
    -0.46
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.85
    (0.13)
    -0.77
    (0.23)
    -0.71
    (0.13)
    -0.86
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.332
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.775
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.588
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    8. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle
    Description Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.69
    (0.05)
    -0.74
    (0.09)
    -0.66
    (0.06)
    -0.59
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.99
    (0.11)
    -0.92
    (0.19)
    -0.99
    (0.09)
    -0.67
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.624
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.473
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.787
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.086
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    9. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late
    Description Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.66
    (0.05)
    -0.49
    (0.09)
    -0.57
    (0.05)
    -0.45
    (0.08)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.94
    (0.05)
    -0.87
    (0.08)
    -0.78
    (0.10)
    -0.52
    (0.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.099
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.223
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.473
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.233
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    10. Secondary Outcome
    Title Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities
    Description Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
    Time Frame Baseline, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 29 9 33 10
    Least Squares Mean (Standard Error) [units on a scale]
    -2.43
    (0.10)
    -2.55
    (0.19)
    -1.66
    (0.13)
    -1.50
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.577
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.567
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    11. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation
    Description Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.72
    (0.04)
    -0.69
    (0.07)
    -0.66
    (0.04)
    -0.51
    (0.07)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.89
    (0.05)
    -0.90
    (0.09)
    -1.66
    (0.13)
    -1.50
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.670
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.059
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.930
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.567
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    12. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation
    Description Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.47
    (0.04)
    -0.48
    (0.07)
    -0.44
    (0.05)
    -0.41
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.53
    (0.07)
    -0.61
    (0.12)
    -0.57
    (0.11)
    -0.78
    (0.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.896
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.796
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.571
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.381
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    13. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)
    Description Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -1.15
    (0.06)
    -0.90
    (0.10)
    -1.15
    (0.06)
    -0.81
    (0.10)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.23
    (0.12)
    -1.13
    (0.20)
    -1.41
    (0.12)
    -1.70
    (0.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.038
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.665
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.253
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    14. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)
    Description Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.61
    (0.05)
    -0.65
    (0.09)
    -0.68
    (0.06)
    -0.57
    (0.10)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.98
    (0.11)
    -0.94
    (0.19)
    -1.20
    (0.08)
    -1.18
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.723
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.312
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.853
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.913
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    15. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal
    Description Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.44
    (0.03)
    -0.52
    (0.06)
    -0.40
    (0.03)
    -0.32
    (0.05)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.98
    (0.11)
    -0.94
    (0.19)
    -0.46
    (0.05)
    -0.47
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.234
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.216
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.853
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.908
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    16. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General
    Description Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.91
    (0.05)
    -0.88
    (0.09)
    -0.75
    (0.05)
    -0.49
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.36
    (0.11)
    -1.18
    (0.20)
    -0.94
    (0.13)
    -0.83
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.789
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.414
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.717
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    17. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms
    Description Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.57
    (0.05)
    -0.54
    (0.09)
    -0.55
    (0.06)
    -0.40
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.89
    (0.13)
    -0.77
    (0.22)
    -0.68
    (0.08)
    -0.30
    (0.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.780
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.152
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.637
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.024
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    18. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis
    Description Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.36
    (0.04)
    -0.41
    (0.06)
    -0.52
    (0.05)
    -0.41
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.44
    (82.99)
    -0.53
    (144.40)
    -0.61
    (0.09)
    -0.41
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.517
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.256
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.268
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    19. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight
    Description Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.21
    (0.02)
    -0.20
    (0.04)
    -0.25
    (0.02)
    -0.24
    (0.04)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.44
    (82.99)
    -0.53
    (144.40)
    -0.61
    (0.09)
    -0.41
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.741
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.722
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.268
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    20. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight
    Description Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.08
    (0.01)
    -0.07
    (0.02)
    -0.01
    (0.01)
    -0.01
    (0.02)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.44
    (82.99)
    -0.53
    (144.40)
    -0.61
    (0.09)
    -0.41
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.723
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.949
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.268
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    21. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation
    Description Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.32
    (0.05)
    -0.36
    (0.09)
    -0.45
    (0.05)
    -0.13
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.56
    (0.12)
    -0.26
    (0.20)
    -0.77
    (0.13)
    -0.70
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.682
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.200
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.813
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    22. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity
    Description Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.43
    (0.04)
    -0.49
    (0.07)
    -0.42
    (0.05)
    -0.21
    (0.08)
    9 Month Change (n=29, n=8, n=32, n=10)
    -0.60
    (0.07)
    -0.54
    (0.12)
    -0.63
    (0.08)
    -0.56
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.438
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.692
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.668
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    23. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization
    Description Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.19
    (0.02)
    -0.21
    (0.03)
    -0.15
    (0.02)
    -0.14
    (0.03)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.60
    (0.07)
    -0.54
    (0.12)
    -0.63
    (0.08)
    -0.56
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.588
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.758
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.692
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.668
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    24. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms
    Description Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.15
    (0.02)
    -0.12
    (0.04)
    -0.13
    (0.02)
    -0.11
    (0.03)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.60
    (0.07)
    -0.54
    (0.12)
    -0.63
    (0.08)
    -0.56
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.507
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.466
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.692
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.668
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    25. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms
    Description Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.08
    (0.02)
    -0.06
    (0.03)
    -0.04
    (0.02)
    -0.06
    (0.03)
    9 Month Change (n=29, n=9, n=33, n=10)
    -0.60
    (0.07)
    -0.54
    (0.12)
    -0.63
    (0.08)
    -0.56
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.487
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.678
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.692
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.668
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    26. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness
    Description Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.95
    (0.05)
    -0.88
    (0.09)
    -0.98
    (0.06)
    -0.81
    (0.10)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.16
    (0.09)
    -0.90
    (0.16)
    -1.34
    (9.63)
    -1.24
    (17.77)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.505
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.135
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.175
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    27. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness
    Description Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -0.87
    (0.05)
    -0.74
    (0.08)
    -0.80
    (0.05)
    -0.51
    (0.08)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.23
    (0.08)
    -1.34
    (0.15)
    -0.92
    (0.07)
    -0.85
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.175
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.576
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.676
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    28. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness
    Description Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -1.00
    (0.06)
    -0.95
    (0.09)
    -0.95
    (0.06)
    -0.79
    (0.09)
    9 Month Change (n=29, n=9, n=33, n=10)
    -1.23
    (0.08)
    -1.34
    (0.15)
    -0.92
    (0.07)
    -0.85
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.675
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.139
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.576
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.676
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    29. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).
    Description The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 193 58 193 63
    Total Score (n=192,n=54,n=185,n=61)
    -26.41
    (1.44)
    -18.88
    (2.38)
    -28.67
    (1.52)
    -22.67
    (2.37)
    Tension-Anxiety (n=193,n=58,n=193,n=62)
    -4.37
    (0.26)
    -3.20
    (0.44)
    -4.61
    (0.30)
    -4.05
    (0.49)
    Depression-Dejection (n=193,n=58,n=191,n=62)
    -6.30
    (0.33)
    -4.64
    (0.55)
    -6.78
    (0.34)
    -5.03
    (0.53)
    Anger-Hostility (n=193,n=58,n=192,n=63)
    -4.46
    (0.28)
    -3.09
    (0.46)
    -4.94
    (0.30)
    -3.63
    (0.48)
    Vigor-Activity (n=192,n=55,192,n=63)
    2.55
    (0.29)
    1.82
    (0.49)
    2.57
    (0.32)
    1.48
    (0.51)
    Fatigue-Inertia (n=193,n=57,n=190,n=63)
    -5.30
    (0.36)
    -4.68
    (0.59)
    -6.08
    (0.37)
    -5.54
    (0.59)
    Confusion-Bewilderment (n=192,n=58,n=189,n=62)
    -3.62
    (0.23)
    -2.86
    (0.39)
    -3.56
    (0.25)
    -3.10
    (0.40)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.020
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.324
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.201
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.069
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.368
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.435
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.090
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.313
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    30. Secondary Outcome
    Title Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)
    Description The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).
    Time Frame Baseline, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 29 9 33 9
    Total Score
    -25.67
    (2.83)
    -22.99
    (4.89)
    -28.39
    (2.46)
    -25.51
    (4.68)
    Tension-Anxiety
    -5.36
    (0.51)
    -4.18
    (0.88)
    -4.68
    (0.50)
    -3.50
    (0.94)
    Depression-Dejection
    -7.60
    (0.60)
    -6.49
    (1.04)
    -7.18
    (0.63)
    -5.56
    (1.24)
    Anger-Hostility
    -4.34
    (0.60)
    -3.38
    (1.04)
    -5.98
    (0.40)
    -4.99
    (0.73)
    Vigor-Activity
    2.63
    (0.78)
    3.11
    (1.39)
    2.00
    (0.74)
    3.04
    (1.42)
    Fatigue-Inertia
    -7.43
    (0.73)
    -7.40
    (1.26)
    -6.34
    (0.59)
    -7.03
    (1.17)
    Confusion-Bewilderment
    -3.95
    (0.45)
    -2.47
    (0.79)
    -3.54
    (0.35)
    -3.07
    (0.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.639
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.584
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.251
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.265
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.366
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.257
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.426
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.234
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.765
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.522
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.986
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.602
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.505
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    31. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores
    Description The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    Work Life (n=133,n=43,n=140,n=49)
    -2.47
    (0.22)
    -2.12
    (0.34)
    -1.98
    (0.22)
    -1.22
    (0.36)
    Social Life (n=194,n=59,n=195,n=63)
    -2.93
    (0.19)
    -2.50
    (0.31)
    -2.67
    (0.19)
    -1.97
    (0.30)
    Family Life (n=194,n=59,n=195,n=63)
    -2.81
    (0.19)
    -2.19
    (0.32)
    -2.66
    (0.19)
    -1.56
    (0.31)
    Total Score (n=195,n=59,n=195,n=63)
    -8.32
    (0.53)
    -6.84
    (0.87)
    -7.70
    (0.52)
    -4.94
    (0.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.366
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.065
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.229
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.092
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.142
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score(Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    32. Secondary Outcome
    Title Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores
    Description The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
    Time Frame Baseline, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 29 9 33 10
    Work Life (n=22, n=8, n=22, n=7)
    -3.88
    (0.69)
    -4.01
    (1.10)
    -2.26
    (0.37)
    -2.16
    (0.66)
    Social Life (n=29, n=9, n=33, n=10)
    -4.15
    (0.37)
    -4.35
    (0.65)
    -3.88
    (0.33)
    -3.66
    (0.62)
    Family Life (n=29, n=9, n=33, n=10)
    -3.46
    (0.36)
    -2.99
    (0.64)
    -3.30
    (0.34)
    -3.07
    (0.66)
    Total Score (n=29, n=9, n=33, n=10)
    -11.60
    (1.02)
    -11.15
    (1.79)
    -9.42
    (0.97)
    -8.67
    (1.88)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.921
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.895
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.789
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.761
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.519
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.755
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.829
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.723
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    33. Secondary Outcome
    Title Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7
    Description Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.
    Time Frame Over 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A - Ordinary Coefficient Group A - Standardized Coefficient Group B - Ordinary Coefficient Group B - Standardized Coefficient
    Arm/Group Description Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
    Measure Participants 214 102 220 110
    Direct Treatment Effect
    -0.032
    -0.012
    0.219
    0.087
    Indirect Treatment Effect from BPOMS Total Score
    0.376
    0.145
    0.209
    0.083
    Total Treatment Effect
    0.343
    0.132
    0.428
    0.170
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.753
    Comments P-value for Direct Treatment Effect
    Method Regression, Linear
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.036
    Comments P-value for Direct Treatment Effect
    Method Regression, Linear
    Comments
    34. Secondary Outcome
    Title Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect
    Description For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.
    Time Frame over 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group B - Percent of Total Effect
    Arm/Group Description The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
    Measure Participants 214
    Direct Treatment Effect
    51.14
    Indirect Treatment Effect from BPOMS Total Score
    48.86
    Total Treatment Effect
    100.00
    35. Secondary Outcome
    Title Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score
    Description Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.
    Time Frame over 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A - Ordinary Coefficient Group A - Standardized Coefficient Group B - Ordinary Coefficient Group B - Standardized Coefficient
    Arm/Group Description Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
    Measure Participants 214 102 220 110
    Direct Treatment Effect
    -0.577
    -0.032
    0.955
    0.052
    Indirect Treatment Effect from BPOMS Total Score
    2.754
    0.151
    1.761
    0.095
    Total Treatment Effect
    2.177
    0.120
    2.716
    0.147
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.342
    Comments P-value for Direct Treatment Effect
    Method Regression, Linear
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.111
    Comments P-value for Direct Treatment Effect
    Method Regression, Linear
    Comments
    36. Secondary Outcome
    Title Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect
    Description For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.
    Time Frame Over 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group B - Percent of Total Effect
    Arm/Group Description The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
    Measure Participants 214
    Direct Treatment Effect
    35.17
    Indirect Treatment Effect from BPOMS Total Score
    64.83
    Total Treatment Effect
    100.00
    37. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score
    Description A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 58 194 62
    12 Week Change
    -6.31
    (0.34)
    -5.65
    (0.55)
    -6.54
    (0.33)
    -5.21
    (0.52)
    9 Month Change (n=29, n=9, n=33, n=9)
    -8.41
    (0.77)
    -6.85
    (1.36)
    -7.17
    (0.59)
    -6.15
    (1.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.302
    Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.325
    Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.423
    Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    38. Secondary Outcome
    Title Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint
    Description Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.
    Time Frame 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week HAMD-17 Total (n=194,n=59,n=195,n=64)
    0.38
    (0.21)
    0.35
    (0.31)
    0.35
    (0.19)
    0.18
    (0.34)
    12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62)
    0.30
    (0.19)
    0.30
    (0.30)
    0.33
    (0.17)
    0.19
    (0.30)
    9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10)
    0.63
    (0.35)
    0.62
    (0.63)
    0.70
    (0.36)
    0.57
    (0.65)
    9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9)
    0.71
    (0.31)
    0.54
    (0.51)
    0.71
    (0.35)
    0.64
    (0.66)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.731
    Comments P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.948
    Comments P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.950
    Comments P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.442
    Comments P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.218
    Comments P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.648
    Comments P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    39. Secondary Outcome
    Title Probability of Response at 12 Week Endpoint
    Description Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    HAMD-17 Total Score (n=194,n=59,n=195,n=64)
    0.63
    (0.16)
    0.60
    (0.27)
    0.63
    (0.16)
    0.46
    (0.26)
    QIDS16 Total Score (n=194,n=58,n=194,n=62)
    0.44
    (0.15)
    0.41
    (0.26)
    0.45
    (0.16)
    0.34
    (0.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.653
    Comments P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.665
    Comments P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.127
    Comments P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.
    Method Mixed Models Analysis
    Comments
    40. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)
    Description Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 193 63
    Item 1 - 12 Week Change
    -1.14
    (0.16)
    -1.35
    (0.26)
    -0.96
    (0.18)
    -1.16
    (0.30)
    Item 7 - 12 Week Change
    -1.33
    (0.17)
    -1.73
    (0.27)
    -1.14
    (0.18)
    -1.36
    (0.30)
    Item 1 - 9 Month Change (n=29, n=9, n=33, n=10)
    -1.30
    (0.41)
    -0.10
    (0.73)
    -2.10
    (0.41)
    -2.36
    (0.75)
    Item 7 - 9 Month Change (n=29, n=9, n=33, n=10)
    -1.56
    (0.42)
    -0.42
    (0.74)
    -2.24
    (0.35)
    -2.11
    (0.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.475
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.561
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.213
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.536
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.158
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.759
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.190
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.852
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    41. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
    Description Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 195 64
    12 Week Change
    -1.93
    (0.08)
    -1.58
    (0.14)
    -1.97
    (0.09)
    -1.25
    (0.15)
    9 Month Change (n=29, n=9, n=33, n=10)
    -2.14
    (0.22)
    -1.97
    (0.40)
    -2.61
    (0.21)
    -2.23
    (0.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.032
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.705
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.388
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    42. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
    Description A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 193 59 194 64
    12 Week Change
    -7.60
    (0.46)
    -6.39
    (0.74)
    -7.96
    (0.47)
    -6.85
    (0.74)
    9 Month Change (n=29, n=9, n=32, n=10)
    -7.17
    (0.88)
    -7.13
    (1.54)
    -8.19
    (0.84)
    -6.77
    (1.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.161
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.198
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.982
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.407
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    43. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score
    Description A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 187 57 185 62
    12 Week Change
    7.18
    (0.62)
    3.40
    (0.99)
    7.54
    (0.61)
    4.52
    (0.92)
    9 Month Change (n=28, n=9, n=30, n=10)
    8.00
    (1.14)
    5.30
    (1.92)
    13.81
    (1.04)
    9.28
    (1.92)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.231
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.040
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    44. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure
    Description Sitting systolic and diastolic blood pressure.
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 58 196 63
    Systolic Blood Pressure (SBP) - 12 Week Change
    -0.12
    (0.78)
    0.05
    (1.33)
    0.73
    (0.76)
    -2.95
    (1.25)
    Diastolic Blood Pressure (DBP) - 12 Week Change
    0.48
    (0.51)
    -0.58
    (0.88)
    1.97
    (0.61)
    -0.50
    (1.00)
    SBP - 9 Month Change (n=28, n=9, n=33, n=10)
    -1.18
    (2.31)
    -0.44
    (4.02)
    -2.22
    (1.63)
    -0.54
    (2.91)
    DBP - 9 Month Change (n=28, n=9, n=33, n=10)
    -2.25
    (1.25)
    1.46
    (2.18)
    -1.52
    (1.47)
    -1.05
    (2.69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.914
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.296
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.874
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.614
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.146
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.877
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    45. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 58 196 63
    12 Week Change
    1.40
    (0.57)
    -1.52
    (1.01)
    0.68
    (0.70)
    -2.05
    (1.18)
    9 Month Change (n=28, n=9, n=33, n=10)
    1.08
    (1.79)
    -0.30
    (3.11)
    1.18
    (1.17)
    -3.04
    (2.05)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.701
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.081
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    46. Secondary Outcome
    Title Change From Baseline to 12 Week and 9 Month Endpoints in Weight
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 58 195 63
    12 Week Change
    -0.54
    (0.20)
    0.38
    (0.31)
    -0.38
    (0.20)
    -0.23
    (0.30)
    9 Month Change (n=28, n=9, n=33, n=10)
    -1.18
    (2.31)
    -0.44
    (4.02)
    -0.94
    (0.55)
    0.06
    (1.02)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.672
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.874
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.390
    Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
    Method Mixed Models Analysis
    Comments
    47. Secondary Outcome
    Title Abnormal Vital Signs at Anytime Over 12 Weeks
    Description
    Time Frame over 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants wtih a normal baseline and at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 250 120 254 128
    Sitting Pulse Rate - High
    1
    0.4%
    0
    0%
    1
    0.4%
    0
    0%
    Weight - Gain
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Weight - Loss
    0
    0%
    1
    0.8%
    2
    0.8%
    0
    0%
    Sitting Systolic Blood Pressure - High
    3
    1.2%
    1
    0.8%
    6
    2.3%
    0
    0%
    Sitting Diastolic Blood Pressure - High
    2
    0.8%
    0
    0%
    2
    0.8%
    3
    2.3%
    48. Secondary Outcome
    Title Abnormal Vital Signs at Anytime Over 9 Months
    Description
    Time Frame over 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline and at least oone post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 250 120 254 128
    Sitting Pulse - High
    1
    0.4%
    0
    0%
    2
    0.8%
    0
    0%
    Weight - Gain
    2
    0.8%
    0
    0%
    3
    1.1%
    0
    0%
    Weight - Loss
    5
    1.9%
    1
    0.8%
    5
    1.9%
    0
    0%
    Sitting Systolic Blood Pressure - High
    4
    1.6%
    2
    1.6%
    7
    2.7%
    0
    0%
    Sitting Diastolic Blood Pressure - High
    2
    0.8%
    0
    0%
    4
    1.5%
    3
    2.3%
    49. Secondary Outcome
    Title Abnormal Vital Signs at 12 Week Endpoint
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline and at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 250 120 254 128
    Sitting Pulse Rate - High
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Weight - Gain
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Weight - Loss
    0
    0%
    1
    0.8%
    2
    0.8%
    0
    0%
    Sitting Systolic Blood Pressure - High
    0
    0%
    0
    0%
    4
    1.5%
    0
    0%
    Sitting Diastolic Blood Pressure - High
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    50. Secondary Outcome
    Title Abnormal Vital Signs at 9 Month Endpoint
    Description
    Time Frame 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline and at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 250 120 254 128
    Sitting Pulse - High
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Weight - Gain
    2
    0.8%
    0
    0%
    3
    1.1%
    0
    0%
    Weight - Loss
    5
    1.9%
    1
    0.8%
    4
    1.5%
    0
    0%
    Sitting Systolic Blood Pressure - High
    1
    0.4%
    0
    0%
    4
    1.5%
    0
    0%
    Sitting Diastolic Blood Pressure - High
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    51. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 214 102 220 110
    Bilirubin - 12 Week Change
    0.10
    (4.09)
    -0.19
    (3.63)
    -0.51
    (3.92)
    0.13
    (3.64)
    Creatinine - 12 Week Change
    -1.56
    (9.55)
    -0.85
    (8.27)
    -1.21
    (8.95)
    0.82
    (7.85)
    Uric Acid - 12 Week Change
    -2.77
    (48.20)
    5.74
    (41.92)
    -12.36
    (46.02)
    7.05
    (44.20)
    Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66)
    -0.13
    (4.04)
    -0.12
    (2.94)
    -0.56
    (3.77)
    0.25
    (3.56)
    Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66)
    -2.11
    (48.77)
    -2.25
    (42.59)
    -8.66
    (47.85)
    6.50
    (44.80)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.046
    Comments P-value for Bilirubin - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments P-value for Creatinine - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value for Uric Acid - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments P-value for Bilirubin - 9 Month Change.
    Method ANOVA
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments P-value for Uric Acid - 9 Month Change.
    Method ANOVA
    Comments
    52. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 191 57 196 67
    Hematocrit - 12 Week Change
    -0.00
    (0.03)
    -0.01
    (0.03)
    0.00
    (0.03)
    -0.01
    (0.03)
    Hematocrit - 9 Month Change (n=194,n=59,=197,n=67)
    -0.00
    (0.03)
    -0.00
    (0.03)
    0.00
    (0.03)
    -0.01
    (0.03)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.037
    Comments P-value for Hematocrit - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments P-value for Hematocrit - 9 Month Change.
    Method ANOVA
    Comments
    53. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 191 57 196 67
    MCV - 12 Week Change
    0.98
    (2.85)
    1.30
    (3.30)
    0.71
    (3.23)
    -0.47
    (3.18)
    MCV - 9 Month Change (n=194,n=59,n=197,n=67)
    1.07
    (2.90)
    1.66
    (3.08)
    0.88
    (3.36)
    -0.31
    (3.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments P-value for MCV - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments P-value for MCV - 9 Month Change.
    Method ANOVA
    Comments
    54. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 192 58 202 66
    Chloride - 12 Week Change
    -0.80
    (2.85)
    0.24
    (2.62)
    -0.91
    (2.75)
    -0.39
    (2.51)
    Urea Nitrogen - 12 Week Change
    -0.06
    (1.29)
    0.26
    (1.04)
    0.01
    (1.20)
    0.15
    (1.38)
    Chloride - 9 Month Change (n=193,n=60,n=202,n=66)
    -0.74
    (2.92)
    0.54
    (2.44)
    -0.82
    (2.71)
    -0.31
    (2.40)
    Cholesterol - 9 Month (n=193,n=60,n=202,n=66)
    -0.06
    (0.70)
    -0.30
    (0.78)
    0.04
    (0.75)
    -0.08
    (0.51)
    Sodium - 9 Month Change (n=193,n=60,n=202,n=66)
    -1.67
    (3.30)
    -0.73
    (2.47)
    -1.86
    (3.16)
    -1.73
    (3.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments P-value for Chloride - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments P-value for Urea Nitrogen - 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments P-value for Chloride - 9 Month Change.
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments P-value for Cholesterol - 9 Month Change.
    Method ANOVA
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.043
    Comments P-value for Sodium - 9 Month Change.
    Method ANOVA
    Comments
    55. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count
    Description
    Time Frame Baseline, 12 weeks, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 187 56 193 67
    12 Week Change
    8.11
    (37.00)
    -7.10
    (38.83)
    10.55
    (37.53)
    12.02
    (51.41)
    9 Month Change (n=191, n=58, n=194, n=67)
    8.06
    (37.62)
    -10.17
    (35.73)
    5.96
    (39.44)
    10.18
    (51.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments P-value for 12 Week Change.
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value for 9 Month Change.
    Method ANOVA
    Comments
    56. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase
    Description
    Time Frame baseline, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 193 60 202 66
    Least Squares Mean (Standard Deviation) [Units per Liter]
    -0.18
    (10.61)
    -2.30
    (10.20)
    0.23
    (10.94)
    -3.75
    (8.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments
    Method ANOVA
    Comments
    57. Secondary Outcome
    Title Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin
    Description
    Time Frame Baseline, 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with non-missing data at baseline and at least one post-baseline visit.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 197 67
    Least Squares Mean (Standard Deviation) [millimoles per Liter (iron)]
    -0.13
    (0.45)
    -0.19
    (0.54)
    -0.01
    (0.47)
    -0.17
    (0.53)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments
    Method ANOVA
    Comments
    58. Secondary Outcome
    Title Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint
    Description The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.
    Time Frame over 3 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline and at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 191 57 201 66
    Lymphocytes - High (n=186,n=57,n=195,n=66)
    1
    0.4%
    3
    2.4%
    2
    0.8%
    1
    0.8%
    Potassium - Low (n=191,n=57,n=201,n=66)
    0
    0%
    0
    0%
    1
    0.4%
    3
    2.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    Comments P-value for Lymphocytes - High.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.048
    Comments P-value for Potassium - Low.
    Method Fisher Exact
    Comments
    59. Secondary Outcome
    Title Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months
    Description
    Time Frame over 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline at at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 194 59 202 67
    Lymphocytes - High (n=189,n=59,n=196,n=66)
    1
    0.4%
    4
    3.1%
    2
    0.8%
    1
    0.8%
    Potassium - Low (n=194,n=59,n=202,n=67)
    0
    0%
    0
    0%
    1
    0.4%
    3
    2.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments P-value for Lymphocytes - High.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.049
    Comments P-value for Potassium - Low.
    Method Fisher Exact
    Comments
    60. Secondary Outcome
    Title Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint
    Description
    Time Frame 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a normal baseline and at least one post-baseline measurement.
    Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 189 59 196 66
    Lymphocytes - High (n=189,n=59,n=196,n=66)
    1
    0.4%
    4
    3.1%
    1
    0.4%
    1
    0.8%
    Hemoglobin - Low (n=184,n=54,n=184,n=63)
    5
    1.9%
    2
    1.6%
    2
    0.8%
    4
    3.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments P-value for Lymphocytes - High.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.038
    Comments P-value for Hemoglobin - Low.
    Method Fisher Exact
    Comments
    61. Secondary Outcome
    Title Summary of Adverse Events Leading to Discontinuation
    Description
    Time Frame over 9 months

    Outcome Measure Data

    Analysis Population Description
    Number of randomized participants in each treatment group.
    Arm/Group Title Duloxetine (Not Escalated) Duloxetine (Escalated) Placebo (Not Rescued) Placebo (Rescued)
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months. duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    Measure Participants 247 271 104 154
    Nausea
    5
    1.9%
    0
    0%
    0
    0%
    1
    0.8%
    Dizziness
    2
    0.8%
    1
    0.8%
    1
    0.4%
    1
    0.8%
    Headache
    1
    0.4%
    0
    0%
    2
    0.8%
    1
    0.8%
    Rash
    2
    0.8%
    0
    0%
    1
    0.4%
    0
    0%
    Fatigue
    2
    0.8%
    2
    1.6%
    0
    0%
    0
    0%
    Insomnia
    2
    0.8%
    1
    0.8%
    0
    0%
    0
    0%
    Suicide attempt
    1
    0.4%
    1
    0.8%
    1
    0.4%
    0
    0%
    Weight increased
    0
    0%
    0
    0%
    2
    0.8%
    0
    0%
    Abdominal pain lower
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Abnormal dreams
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Asthma
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Blood pressure increased
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Chest pain
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Completed suicide
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Constipation
    2
    0.8%
    1
    0.8%
    0
    0%
    0
    0%
    Crying
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Depression
    0
    0%
    1
    0.8%
    1
    0.4%
    0
    0%
    Diarrhoea
    1
    0.4%
    1
    0.8%
    0
    0%
    1
    0.8%
    Disturbance in attention
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Dry mouth
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Dysgeusia
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Hepatic function abnormal
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Hernia
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Hyperhidrosis
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Hypertension
    1
    0.4%
    1
    0.8%
    0
    0%
    1
    0.8%
    Influenza
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Irritability
    1
    0.4%
    0
    0%
    1
    0.4%
    0
    0%
    Lower gastrointestinal haemorrhage
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Lower limb fracture
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Mania
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Migraine
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Muscular weakness
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Non-cardiac chest pain
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Paranoia
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Pregnancy
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Restlessness
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Road traffic accident
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Ruptured cerebral aneurysm
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Pneumonia
    1
    0.4%
    0
    0%
    0
    0%
    1
    0.8%
    Tremor
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Urinary hesitation
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Urinary retention
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Wound infection staphylococcal
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    Anorgasmia
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Astigmatism
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Cardiac failure congestive
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Depressive symptom
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Dyspepsia
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Gamma-glutamyltransferase increased
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Hepatic enzyme increased
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Libido decreased
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Night sweats
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Myocardial infarction
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Nightmare
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Palpitations
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Pruritus
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Sexual dysfunction
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%
    Somnolence
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Sedation
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Vomiting
    0
    0%
    1
    0.8%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Duloxetine Placebo
    Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
    All Cause Mortality
    Duloxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Duloxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/ (NaN) 14/ (NaN)
    Cardiac disorders
    Cardiac failure congestive 1/518 (0.2%) 1 0/258 (0%) 0
    Myocardial infarction 0/518 (0%) 0 1/258 (0.4%) 1
    Pericardial effusion 1/518 (0.2%) 1 0/258 (0%) 0
    Pericarditis 1/518 (0.2%) 1 0/258 (0%) 0
    Gastrointestinal disorders
    Colitis 1/518 (0.2%) 1 0/258 (0%) 0
    Gastrointestinal haemorrhage 0/518 (0%) 0 1/258 (0.4%) 1
    General disorders
    Fatigue 1/518 (0.2%) 1 0/258 (0%) 0
    Non-cardiac chest pain 1/518 (0.2%) 1 0/258 (0%) 0
    Hepatobiliary disorders
    Biliary colic 0/518 (0%) 0 1/258 (0.4%) 1
    Infections and infestations
    Diverticulitis 0/518 (0%) 0 1/258 (0.4%) 1
    Gangrene 0/518 (0%) 0 1/258 (0.4%) 1
    Gastroenteritis 1/518 (0.2%) 1 0/258 (0%) 0
    Oesophageal candidiasis 0/518 (0%) 0 1/258 (0.4%) 1
    Pneumonia 1/518 (0.2%) 1 1/258 (0.4%) 1
    Pyelonephritis 1/518 (0.2%) 1 0/258 (0%) 0
    Sepsis 0/518 (0%) 0 1/258 (0.4%) 1
    Sinusitis 1/518 (0.2%) 1 0/258 (0%) 0
    Staphylococcal infection 1/518 (0.2%) 1 1/258 (0.4%) 1
    Subcutaneous abscess 1/518 (0.2%) 1 0/258 (0%) 0
    Tooth infection 1/518 (0.2%) 1 0/258 (0%) 0
    Urinary tract infection 0/518 (0%) 0 1/258 (0.4%) 1
    Wound infection staphylococcal 0/518 (0%) 0 1/258 (0.4%) 1
    Injury, poisoning and procedural complications
    Lower limb fracture 0/518 (0%) 0 1/258 (0.4%) 1
    Road traffic accident 1/518 (0.2%) 1 0/258 (0%) 0
    Metabolism and nutrition disorders
    Hyperglycaemia 0/518 (0%) 0 1/258 (0.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial cancer metastatic 1/518 (0.2%) 1 0/258 (0%) 0
    Nervous system disorders
    Ruptured cerebral aneurysm 1/518 (0.2%) 1 0/258 (0%) 0
    Status migrainosus 1/518 (0.2%) 1 0/258 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Ruptured ectopic pregnancy 1/518 (0.2%) 1 0/258 (0%) 0
    Psychiatric disorders
    Completed suicide 0/518 (0%) 0 1/258 (0.4%) 1
    Depression 1/518 (0.2%) 1 1/258 (0.4%) 1
    Homicidal ideation 1/518 (0.2%) 1 0/258 (0%) 0
    Suicide attempt 2/518 (0.4%) 2 1/258 (0.4%) 1
    Reproductive system and breast disorders
    Ovarian cyst 1/518 (0.2%) 1 0/258 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/518 (0%) 0 1/258 (0.4%) 1
    Pleural effusion 1/518 (0.2%) 1 0/258 (0%) 0
    Vascular disorders
    Deep vein thrombosis 1/518 (0.2%) 1 0/258 (0%) 0
    Other (Not Including Serious) Adverse Events
    Duloxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 497/ (NaN) 237/ (NaN)
    Endocrine disorders
    Hypothyroidism 19/518 (3.7%) 19 15/258 (5.8%) 15
    Gastrointestinal disorders
    Constipation 63/518 (12.2%) 71 30/258 (11.6%) 32
    Diarrhoea 62/518 (12%) 69 30/258 (11.6%) 33
    Dry mouth 95/518 (18.3%) 98 36/258 (14%) 38
    Dyspepsia 33/518 (6.4%) 34 16/258 (6.2%) 16
    Flatulence 24/518 (4.6%) 24 13/258 (5%) 14
    Gastrooesophageal reflux disease 49/518 (9.5%) 49 26/258 (10.1%) 26
    Nausea 123/518 (23.7%) 155 37/258 (14.3%) 45
    General disorders
    Fatigue 49/518 (9.5%) 52 20/258 (7.8%) 24
    Irritability 22/518 (4.2%) 22 16/258 (6.2%) 17
    Immune system disorders
    Seasonal allergy 65/518 (12.5%) 65 35/258 (13.6%) 35
    Infections and infestations
    Nasopharyngitis 47/518 (9.1%) 48 19/258 (7.4%) 24
    Sinusitis 23/518 (4.4%) 24 18/258 (7%) 19
    Upper respiratory tract infection 38/518 (7.3%) 42 20/258 (7.8%) 25
    Metabolism and nutrition disorders
    Hypercholesterolaemia 44/518 (8.5%) 44 20/258 (7.8%) 20
    Type 2 diabetes mellitus 8/518 (1.5%) 8 13/258 (5%) 13
    Musculoskeletal and connective tissue disorders
    Arthralgia 39/518 (7.5%) 42 20/258 (7.8%) 21
    Arthritis 28/518 (5.4%) 28 9/258 (3.5%) 9
    Back pain 79/518 (15.3%) 85 35/258 (13.6%) 36
    Osteoarthritis 28/518 (5.4%) 29 6/258 (2.3%) 6
    Nervous system disorders
    Dizziness 58/518 (11.2%) 68 28/258 (10.9%) 30
    Headache 177/518 (34.2%) 221 83/258 (32.2%) 96
    Migraine 48/518 (9.3%) 51 18/258 (7%) 18
    Somnolence 24/518 (4.6%) 25 13/258 (5%) 14
    Tension headache 22/518 (4.2%) 25 14/258 (5.4%) 14
    Psychiatric disorders
    Anxiety 27/518 (5.2%) 30 24/258 (9.3%) 28
    Insomnia 69/518 (13.3%) 72 38/258 (14.7%) 42
    Respiratory, thoracic and mediastinal disorders
    Asthma 42/518 (8.1%) 43 19/258 (7.4%) 19
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 27/518 (5.2%) 27 6/258 (2.3%) 6
    Vascular disorders
    Hypertension 100/518 (19.3%) 101 56/258 (21.7%) 57

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00536471
    Other Study ID Numbers:
    • 11669
    • F1J-US-HMFS
    First Posted:
    Sep 27, 2007
    Last Update Posted:
    Nov 20, 2009
    Last Verified:
    Nov 1, 2009