Duloxetine for Chronic Depression: a Double-blind Study

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00360724
Collaborator
Eli Lilly and Company (Industry)
65
1
2
88
0.7

Study Details

Study Description

Brief Summary

The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).

Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.

Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.

Condition or Disease Intervention/Treatment Phase
  • Drug: Duloxetine (Cymbalta)
Phase 4

Detailed Description

This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).

The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.

Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.

In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Duloxetine for Chronic Depression: a Double-blind Study
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: duloxetine (cymbalta)

Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine

Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
  • duloxetine
  • Cymbalta
  • Placebo Comparator: Placebo treatment

    placebo treatment: treatment with placebo capsules that match active medication capsules

    Drug: Duloxetine (Cymbalta)
    duloxetine medication up to dose of 120 mg/day
    Other Names:
  • duloxetine
  • Cymbalta
  • Outcome Measures

    Primary Outcome Measures

    1. Hamilton Depression Rating Scale (HDRS) - 24 Total Score [Week 10]

      HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

    2. Hamilton Depression Rating Scale (HDRS) - 24 Total Score [Baseline]

      HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

    Secondary Outcome Measures

    1. Cornell Dysthymia Rating Scale (CDRS) [Week 10]

      CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression

    2. Global Assessment of Functioning Scale (GAF) [Week 10]

      A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information

    3. Beck Depression Inventory (BDI) [Week 10]

      Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.

    4. Clinical Global Impressions Improvement(CGI-I) [10 weeks]

      The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline. 0 = Not assessed = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse Higher score=greatest worsening

    5. Cornell Dysthymia Rating Scale (CDRS) [Baseline]

      CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression

    6. Beck Depression Inventory (BDI) [Baseline]

      Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.

    7. Global Assessment of Functioning Scale (GAF) [Baseline]

      A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information

    Other Outcome Measures

    1. Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [Baseline]

      To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.

    2. Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [Follow up]

      To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age 20 to 75 years (ages 20 to 60 for MRI sub-study)

    • diagnosis of dysthymic disorder (chronic depression) or depression NOS

    • minimum of 2 years duration of current episode of depression

    Exclusion Criteria:
    • current major depression

    • diagnoses including delirium, dementia, bipolar disorder, schizophrenia

    • substance abuse or dependence in the past 6 months

    • pregnant or nursing women

    • serious risk of suicide

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Psychiatric Institute New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute
    • Eli Lilly and Company

    Investigators

    • Principal Investigator: David J. Hellerstein, MD, New York State Psychiatric Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT00360724
    Other Study ID Numbers:
    • # 4967/6363R
    First Posted:
    Aug 7, 2006
    Last Update Posted:
    Aug 21, 2017
    Last Verified:
    Jul 1, 2017

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited by advertisements, website postings, and from the hospital's telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology.
    Pre-assignment Detail For patients on current ineffective psychotropic medication, washout was required, with >=7 days medication-free (>=28 days for fluoxetine). Concurrent sleep medication (zolpidem) was allowed for a maximum of 5 days during the study.
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment, treatment with matching capsules of placebo
    Period Title: Overall Study
    STARTED 33 32
    COMPLETED 29 28
    NOT COMPLETED 4 4

    Baseline Characteristics

    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment Total
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules Total of all reporting groups
    Overall Participants 33 32 65
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    32
    97%
    32
    100%
    64
    98.5%
    >=65 years
    1
    3%
    0
    0%
    1
    1.5%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41
    (11.7)
    42.1
    (11.4)
    41.6
    (11.2)
    Sex: Female, Male (Count of Participants)
    Female
    18
    54.5%
    10
    31.3%
    28
    43.1%
    Male
    15
    45.5%
    22
    68.8%
    37
    56.9%
    Region of Enrollment (participants) [Number]
    United States
    33
    100%
    32
    100%
    65
    100%

    Outcome Measures

    1. Primary Outcome
    Title Hamilton Depression Rating Scale (HDRS) - 24 Total Score
    Description HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment, with capsules matching the duloxetine medication
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    5
    (3.6)
    10
    (5.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments Repeated measures ANOVA was used to compare measures between baseline and week 10.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value .003
    Comments
    Method Repeated Measures ANOVA
    Comments df 1,55
    Method of Estimation Estimation Parameter F statistics
    Estimated Value 9.43
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments time X Drug group, f=9.43,df 1,55, p=.003
    2. Primary Outcome
    Title Hamilton Depression Rating Scale (HDRS) - 24 Total Score
    Description HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment, with capsules matching the duloxetine medication
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    14.1
    (3.8)
    14.9
    (3.5)
    3. Secondary Outcome
    Title Cornell Dysthymia Rating Scale (CDRS)
    Description CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    subjects for whom data post baseline were available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [scores on a scale]
    19.1
    (9.5)
    28.5
    (14.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments Repeated measures ANOVA was used to compare measures between baseline and week 10.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method Repeated Measures ANOVA
    Comments d.f. 1,55
    Method of Estimation Estimation Parameter F statistics
    Estimated Value 8.72
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Time x Treatment: F=8.72, d.f=1,55, p=0.05
    4. Secondary Outcome
    Title Global Assessment of Functioning Scale (GAF)
    Description A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    subjects for whom post-baseline data were available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [points on rating scale]
    69.9
    (20.9)
    65.7
    (14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments Repeated measures ANOVA was used to compare measures between baseline and week 10.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.025
    Comments
    Method Repeated measures ANOVA
    Comments d.f. 1,55
    Method of Estimation Estimation Parameter F statistics
    Estimated Value 5.33
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Beck Depression Inventory (BDI)
    Description Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    subjects fro whom post-baseline data was available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    8.5
    (7)
    10.1
    (6.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments Repeated measures ANOVA was used to compare measures between baseline and week 10.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6
    Comments
    Method Repeated measures ANOVA
    Comments d.f.=1,55
    Method of Estimation Estimation Parameter F statistics
    Estimated Value 0.26
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Clinical Global Impressions Improvement(CGI-I)
    Description The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline. 0 = Not assessed = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse Higher score=greatest worsening
    Time Frame 10 weeks

    Outcome Measure Data

    Analysis Population Description
    subjects for whom post-baseline data was available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    2.4
    (.8)
    3
    (1.1)
    7. Secondary Outcome
    Title Cornell Dysthymia Rating Scale (CDRS)
    Description CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    subjects for whom data post baseline were available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    36.9
    (8.0)
    37.4
    (8.0)
    8. Secondary Outcome
    Title Beck Depression Inventory (BDI)
    Description Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    subjects for whom post-baseline data was available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [Scores on a scale]
    12.7
    (5.8)
    15.5
    (5.5)
    9. Secondary Outcome
    Title Global Assessment of Functioning Scale (GAF)
    Description A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    subjects for whom post-baseline data were available
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    Measure Participants 29 28
    Mean (Standard Deviation) [points on rating scale]
    62.6
    (5.8)
    58.3
    (7.0)
    10. Other Pre-specified Outcome
    Title Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
    Description To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day
    Measure Participants 15 17
    Mean (Standard Deviation) [percentage of connecting nods]
    0.21
    (0.08)
    0.24
    (0.06)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.0
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Other Pre-specified Outcome
    Title Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
    Description To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
    Time Frame Follow up

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day
    Measure Participants 15 17
    Mean (Standard Deviation) [percentage of connecting nods]
    0.16
    (0.06)
    0.19
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Duloxetine (Cymbalta), Placebo Treatment
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.4
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment.
    Adverse Event Reporting Description All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
    Arm/Group Title Duloxetine (Cymbalta) Placebo Treatment
    Arm/Group Description Duloxetine medication, ranging from 30 to 120 mg/day placebo treatment: treatment with placebo capsules that match active medication capsules
    All Cause Mortality
    Duloxetine (Cymbalta) Placebo Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Duloxetine (Cymbalta) Placebo Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/33 (0%) 0/32 (0%)
    Other (Not Including Serious) Adverse Events
    Duloxetine (Cymbalta) Placebo Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 27/29 (93.1%) 22/28 (78.6%)
    Gastrointestinal disorders
    GI upset 7/29 (24.1%) 7 9/28 (32.1%) 9
    General disorders
    Fatigue 9/29 (31%) 9 8/28 (28.6%) 8
    Nausea 6/29 (20.7%) 6 5/28 (17.9%) 5
    Dizziness 2/29 (6.9%) 2 4/28 (14.3%) 4
    Decreased Sleep 6/29 (20.7%) 6 4/28 (14.3%) 4
    Decreased Appetite 8/29 (27.6%) 8 4/28 (14.3%) 4
    Vivid Dream 7/29 (24.1%) 7 1/28 (3.6%) 1

    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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title David Hellerstein MD
    Organization NY State Psychiatric Institute
    Phone 6467748000
    Email hellers@nyspi.columbia.edu
    Responsible Party:
    New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT00360724
    Other Study ID Numbers:
    • # 4967/6363R
    First Posted:
    Aug 7, 2006
    Last Update Posted:
    Aug 21, 2017
    Last Verified:
    Jul 1, 2017