TRY FIRST: A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00666757
Collaborator
Boehringer Ingelheim (Industry)
750
61
5
10
12.3
1.2
Study Details
Study Description
Brief Summary
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Feb 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: duloxetine study drug |
Drug: duloxetine
30-120 milligrams (mgs) orally daily for 12 weeks
Other Names:
|
| Active Comparator: citalopram
|
Drug: citalopram
20-40 mgs orally daily for 12 weeks
|
| Active Comparator: fluoxetine
|
Drug: fluoxetine
20-80 mgs orally daily for 12 weeks
|
| Active Comparator: paroxetine
|
Drug: paroxetine
20-50 mgs orally daily for 12 weeks
|
| Active Comparator: sertraline
|
Drug: sertraline
50-200 mgs orally daily for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] [12 weeks]
Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.
Secondary Outcome Measures
- Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 weeks]
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.
- Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] [12 weeks]
Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.
- Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] [Baseline, 12-Weeks]
Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
- Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] [Baseline, 12-Weeks]
Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
- Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 Weeks]
The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).
- Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 Weeks]
HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.
- Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 weeks]
HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
- Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 Weeks]
HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).
- Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 Weeks]
The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).
- Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) [Baseline, 12 Weeks]
The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
- Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) [Baseline, 12 Weeks]
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.
- Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) [Baseline, 12 weeks]
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.
- Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) [Baseline, 12 weeks]
The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.
- Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) [Baseline, 12 Weeks]
The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
- Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) [Baseline, 12 Weeks]
The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
- Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) [Baseline, 12 Weeks]
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
- Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint [Baseline, 12 Weeks]
Mean change from baseline to endpoint in systolic blood pressure
- Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint [Baseline, 12 Weeks]
Mean change from baseline to endpoint in diastolic blood pressure
- Change From Baseline in Pulse Rate at Week-12 Endpoint [Baseline, 12 Weeks]
Mean change from baseline to endpoint in pulse rate
- Change From Baseline in Weight at Week-12 Endpoint [Baseline, 12 Weeks]
Mean change from baseline to endpoint in weight
Other Outcome Measures
- Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint [Baseline, 12 Weeks]
WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.
- Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint [Baseline, 12 weeks]
Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]). Mean change baseline to endpoint.
- Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint [Baseline, 12 Weeks]
Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.
- Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint [Baseline, 12 Weeks]
Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between "score for self" and "score for average worker in same job". Mean change baseline to endpoint is reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
At least 18 years of age
-
Have major depression and are currently in a severe depressive episode
-
Have a degree of understanding such that patient can communicate with the investigator and study staff
-
All females must test negative for pregnancy
-
Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Exclusion criteria:
-
Have not responded to duloxetine for depression in the past
-
Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
-
Are at significant risk for suicide
-
Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
-
Have a serious, unstable medical condition
-
Have a current or recent history of substance abuse or dependence
-
Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
-
Have started psychotherapy within 6 weeks prior to study entry
-
Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require 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. | Carson | California | United States | 90746 |
| 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. | Irvine | California | United States | 92618 |
| 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. | San Diego | California | United States | 92108 |
| 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. | Sherman Oaks | California | United States | 91403 |
| 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. | Torrance | California | United States | 90502 |
| 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. | Pueblo | Colorado | United States | 81008 |
| 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. | Clearwater | Florida | United States | 33765 |
| 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. | Coral Springs | Florida | United States | 33065 |
| 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. | Deerfield Beach | Florida | United States | 33064 |
| 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 | 32607 |
| 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. | Hialeah | Florida | United States | 33016 |
| 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. | Melbourne | Florida | United States | 32901 |
| 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. | Miami | Florida | United States | 33173 |
| 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. | Winter Park | Florida | United States | 32789 |
| 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. | Atlanta | Georgia | United States | 30338 |
| 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. | Joliet | Illinois | United States | 60435 |
| 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. | Oak Brook | Illinois | United States | 60523 |
| 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. | Park Ridge | Illinois | United States | 60068 |
| 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. | Greenwood | Indiana | United States | 46143 |
| 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. | Terre Haute | Indiana | United States | 47802 |
| 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. | Prairie Village | Kansas | United States | 66206 |
| 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. | Wichita | Kansas | United States | 67203 |
| 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. | Gaithersburg | Maryland | United States | 20877 |
| 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. | Glen Burnie | Maryland | United States | 21061 |
| 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. | Rockville | Maryland | United States | 20852 |
| 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. | Fall River | Massachusetts | United States | 02721 |
| 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 Louis | Missouri | United States | 63141 |
| 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. | Princeton | New Jersey | United States | 08540 |
| 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. | Brooklyn | New York | United States | 11223 |
| 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. | Fresh Meadows | New York | United States | 11366 |
| 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. | Mount Kisco | New York | United States | 10549 |
| 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. | Rochester | New York | United States | 14618 |
| 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. | Staten Island | New York | United States | 10312 |
| 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. | Concord | North Carolina | United States | 28025 |
| 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. | Durham | North Carolina | United States | 27707 |
| 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. | Beachwood | Ohio | United States | 44122 |
| 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. | Dayton | Ohio | United States | 45432 |
| 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. | Kettering | Ohio | United States | 45429 |
| 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. | Oklahoma City | Oklahoma | United States | 73119 |
| 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. | Eugene | Oregon | United States | 97404 |
| 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. | Havertown | Pennsylvania | United States | 19083 |
| 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. | Media | Pennsylvania | United States | 19063 |
| 45 | 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. | Newtown | Pennsylvania | United States | 18940 |
| 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. | Philadelphia | Pennsylvania | United States | 19139 |
| 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. | Lincoln | Rhode Island | United States | 02865 |
| 48 | 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. | Columbia | South Carolina | United States | 29201 |
| 49 | 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. | Sioux Falls | South Dakota | United States | 57105 |
| 50 | 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. | Austin | Texas | United States | 78756 |
| 51 | 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. | Dallas | Texas | United States | 75231 |
| 52 | 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. | Friendswood | Texas | United States | 77546 |
| 53 | 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. | Houston | Texas | United States | 77074 |
| 54 | 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 |
| 55 | 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 Antonio | Texas | United States | 78229 |
| 56 | 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. | Wichita Falls | Texas | United States | 76309 |
| 57 | 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. | Woodstock | Vermont | United States | 05091 |
| 58 | 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 |
| 59 | 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. | Herndon | Virginia | United States | 20170 |
| 60 | 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. | Bellevue | Washington | United States | 98004 |
| 61 | 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 |
Sponsors and Collaborators
- Eli Lilly and Company
- Boehringer Ingelheim
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM 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:
NCT00666757
Other Study ID Numbers:
- 11715
- F1J-US-HMFT
First Posted:
Apr 25, 2008
Last Update Posted:
Jun 15, 2010
Last Verified:
May 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The United States study started in May 2008 and completed in March 2009. A total of 72 sites participated (65 Psychiatric, 5 Family Practice, and 2 Internal Medicine specialties). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Period Title: Overall Study | ||
| STARTED | 372 | 378 |
| COMPLETED | 272 | 281 |
| NOT COMPLETED | 100 | 97 |
Baseline Characteristics
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks | Total of all reporting groups |
| Overall Participants | 372 | 378 | 750 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.3
(13.01)
|
43.8
(13.05)
|
44.1
(13.02)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
237
63.7%
|
259
68.5%
|
496
66.1%
|
| Male |
135
36.3%
|
119
31.5%
|
254
33.9%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| African Descent |
76
20.4%
|
68
18%
|
144
19.2%
|
| Caucasian |
231
62.1%
|
241
63.8%
|
472
62.9%
|
| East/Southeast Asian |
2
0.5%
|
7
1.9%
|
9
1.2%
|
| Hispanic |
59
15.9%
|
52
13.8%
|
111
14.8%
|
| Western Asian |
1
0.3%
|
2
0.5%
|
3
0.4%
|
| Other |
3
0.8%
|
7
1.9%
|
10
1.3%
|
| Missing |
0
0%
|
1
0.3%
|
1
0.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
372
100%
|
378
100%
|
750
100%
|
| History, Met Diagnosis of Major Mood Disorder (MDD) (participants) [Number] | |||
| Number [participants] |
372
100%
|
378
100%
|
750
100%
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.45
(2.22)
|
7.42
(2.25)
|
7.43
(2.23)
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Bech Subscale Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
12.97
(2.13)
|
13.13
(1.95)
|
13.05
(2.04)
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
12.47
(2.33)
|
12.48
(2.22)
|
12.47
(2.27)
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Subscale (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
8.36
(1.55)
|
8.53
(1.54)
|
8.45
(1.55)
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
4.73
(1.35)
|
4.77
(1.33)
|
4.75
(1.34)
|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
25.03
(4.44)
|
25.03
(4.24)
|
25.03
(4.34)
|
| Brief Pain Inventory (BPI) Average 24-Hour Pain Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.64
(2.74)
|
2.98
(2.79)
|
2.81
(2.77)
|
| History, Age at First Episode (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
31.53
(14.39)
|
30.42
(14.30)
|
30.97
(14.34)
|
| History, Number of Previous MDD Episodes (episodes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [episodes] |
6.74
(15.32)
|
5.09
(11.08)
|
5.91
(13.37)
|
| History, Time Since Most Recent MDD Episode (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
11.76
(19.06)
|
11.92
(30.69)
|
11.84
(25.57)
|
| Quick Inventory of Depressive Symptomatology (QIDS-SR) Total Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
21.64
(1.71)
|
21.70
(1.70)
|
21.67
(1.701)
|
| Sheehan Disability Scale (SDS) Global Functional Impairment Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
22.70
(5.52)
|
22.72
(6.05)
|
22.71
(5.79)
|
| Sheehan Disability Scale (SDS) Item 1: Symptoms Disrupted Work/School (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.00
(2.40)
|
7.09
(2.45)
|
7.05
(2.42)
|
| Sheehan Disability Scale (SDS) Item 2: Symptoms Disrupted Social Life/Leisure Activities (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.81
(1.97)
|
7.82
(2.13)
|
7.82
(2.05)
|
| Sheehan Disability Scale (SDS) Item 3: Symptoms Disrupted Family Life/Home Responsibilities (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.67
(2.02)
|
7.68
(2.28)
|
7.67
(2.15)
|
| Weight (kilograms (kg)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms (kg)] |
86.62
(22.37)
|
86.23
(23.97)
|
86.42
(23.18)
|
| World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Absenteeism (hours lost per week) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [hours lost per week] |
28.64
(59.28)
|
33.29
(72.90)
|
31.00
(66.48)
|
| World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Presenteeism (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
48.85
(22.47)
|
50.63
(23.86)
|
49.74
(23.16)
|
Outcome Measures
| Title | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] |
|---|---|
| Description | Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 273 | 284 |
| Least Squares Mean (Standard Error) [Probability of remission] |
0.36
(0.03)
|
0.32
(0.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 273 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-13.4
(0.36)
|
-12.6
(0.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] |
|---|---|
| Description | Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 272 | 283 |
| Least Squares Mean (Standard Error) [Probability of remission] |
0.53
(0.03)
|
0.44
(0.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] |
|---|---|
| Description | Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Time Frame | Baseline, 12-Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 273 | 284 |
| Least Squares Mean (Standard Error) [Probability of response] |
0.71
(0.03)
|
0.64
(0.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.09 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] |
|---|---|
| Description | Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Time Frame | Baseline, 12-Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 272 | 283 |
| Least Squares Mean (Standard Error) [Probability of response] |
0.73
(0.03)
|
0.61
(0.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 272 | 283 |
| Least Squares Mean (Standard Error) [units on a scale] |
-17.03
(0.43)
|
-15.3
(0.42)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-4.89
(0.16)
|
-4.24
(0.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-9.01
(0.23)
|
-8.16
(0.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-9.21
(0.24)
|
-8.40
(0.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 273 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-5.99
(0.16)
|
-5.49
(0.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) |
|---|---|
| Description | The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 285 |
| Least Squares Mean (Standard Error) [units on a scale] |
-2.77
(0.12)
|
-2.58
(0.12)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) |
|---|---|
| Description | The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 156 | 166 |
| Least Squares Mean (Standard Error) [units on a scale] |
-2.95
(0.21)
|
-2.39
(0.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) |
|---|---|
| Description | The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 249 | 257 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.83
(0.15)
|
-1.43
(0.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) |
|---|---|
| Description | The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 270 | 283 |
| Least Squares Mean (Standard Error) [units on a scale] |
-13.56
(0.53)
|
-11.53
(0.52)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) |
|---|---|
| Description | The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 182 | 192 |
| Least Squares Mean (Standard Error) [units on a scale] |
-4.52
(0.22)
|
-3.85
(0.21)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint |
|---|---|
| Description | WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Last Observation Carried Forward. |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 130 | 132 |
| Least Squares Mean (Standard Error) [dollars] |
7250.93
(954.77)
|
5074.09
(957.77)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | Between group P-value | |
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint |
|---|---|
| Description | Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]). Mean change baseline to endpoint. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Last Observation Carried Forward. |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 134 | 142 |
| Least Squares Mean (Standard Error) [dollars] |
-3978.98
(1708.92)
|
-1932.46
(1689.85)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | Between group P-value | |
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) |
|---|---|
| Description | The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 271 | 283 |
| Least Squares Mean (Standard Error) [units on a scale] |
-4.51
(0.19)
|
-3.94
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) |
|---|---|
| Description | The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 270 | 283 |
| Least Squares Mean (Standard Error) [units on a scale] |
-4.69
(0.18)
|
-4.04
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint |
|---|---|
| Description | Mean change from baseline to endpoint in systolic blood pressure |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 285 |
| Least Squares Mean (Standard Error) [millimeters of mmercury (mmHg)] |
0.58
(0.69)
|
0.55
(0.68)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint |
|---|---|
| Description | Mean change from baseline to endpoint in diastolic blood pressure |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 285 |
| Least Squares Mean (Standard Error) [mmHg] |
-0.14
(0.48)
|
0.45
(0.46)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.32 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint |
|---|---|
| Description | Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Last Observation Carried Forward. |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 137 | 146 |
| Least Squares Mean (Standard Error) [hours lost per week] |
-9.56
(5.14)
|
0.41
(5.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Transformed absolute score | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | Between group P-value | |
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint |
|---|---|
| Description | Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between "score for self" and "score for average worker in same job". Mean change baseline to endpoint is reported. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Last Observation Carried Forward. |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 136 | 139 |
| Least Squares Mean (Standard Error) [units on a scale] |
24.56
(2.14)
|
20.73
(2.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Transformed Absolute Score | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | Between group P-value | |
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in Pulse Rate at Week-12 Endpoint |
|---|---|
| Description | Mean change from baseline to endpoint in pulse rate |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 274 | 285 |
| Least Squares Mean (Standard Error) [beats per minute (bpm)] |
2.74
(0.58)
|
0.47
(0.57)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change From Baseline in Weight at Week-12 Endpoint |
|---|---|
| Description | Mean change from baseline to endpoint in weight |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284 |
| Arm/Group Title | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Arm/Group Description | 30-120 milligrams (mgs) orally daily for 12 weeks | all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks |
| Measure Participants | 273 | 284 |
| Least Squares Mean (Standard Error) [kilograms (kg)] |
-0.32
(0.18)
|
-0.17
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Comments | Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline | |||||
| Arm/Group Description | 30-120 mg orally daily for 12 weeks | 20-40 mg orally daily for 12 weeks | 20-80 mg orally daily for 12 weeks | 20-50 mg orally daily for 12 weeks | 50-200 mg orally daily for 12 weeks | |||||
All Cause Mortality |
||||||||||
| Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/372 (1.1%) | 2/157 (1.3%) | 1/57 (1.8%) | 1/45 (2.2%) | 2/119 (1.7%) | |||||
| Infections and infestations | ||||||||||
| Pneumonia | 0/372 (0%) | 0 | 1/157 (0.6%) | 1 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Cervical vertebral fracture | 0/372 (0%) | 0 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 1/119 (0.8%) | 1 |
| Tibia fracture | 1/372 (0.3%) | 1 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||
| Hyponatraemia | 0/372 (0%) | 0 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 1/45 (2.2%) | 1 | 0/119 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Cerebrovascular accident | 0/372 (0%) | 0 | 0/157 (0%) | 0 | 1/57 (1.8%) | 1 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Temporal lobe epilepsy | 1/372 (0.3%) | 1 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Psychiatric disorders | ||||||||||
| Post-traumatic stress disorder | 0/372 (0%) | 0 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 1/119 (0.8%) | 1 |
| Suicidal ideation | 1/372 (0.3%) | 1 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 1/372 (0.3%) | 1 | 0/157 (0%) | 0 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Chronic obstructive pulmonary disease | 0/372 (0%) | 0 | 1/157 (0.6%) | 1 | 0/57 (0%) | 0 | 0/45 (0%) | 0 | 0/119 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 277/372 (74.5%) | 112/157 (71.3%) | 47/57 (82.5%) | 36/45 (80%) | 86/119 (72.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 33/372 (8.9%) | 35 | 8/157 (5.1%) | 8 | 1/57 (1.8%) | 2 | 2/45 (4.4%) | 2 | 3/119 (2.5%) | 3 |
| Diarrhoea | 36/372 (9.7%) | 41 | 17/157 (10.8%) | 18 | 10/57 (17.5%) | 10 | 3/45 (6.7%) | 3 | 18/119 (15.1%) | 20 |
| Dry mouth | 66/372 (17.7%) | 67 | 16/157 (10.2%) | 16 | 11/57 (19.3%) | 11 | 4/45 (8.9%) | 4 | 13/119 (10.9%) | 13 |
| Nausea | 63/372 (16.9%) | 70 | 17/157 (10.8%) | 18 | 8/57 (14%) | 9 | 8/45 (17.8%) | 8 | 15/119 (12.6%) | 16 |
| General disorders | ||||||||||
| Fatigue | 27/372 (7.3%) | 28 | 10/157 (6.4%) | 10 | 2/57 (3.5%) | 3 | 8/45 (17.8%) | 8 | 3/119 (2.5%) | 3 |
| Infections and infestations | ||||||||||
| Nasopharyngitis | 11/372 (3%) | 11 | 5/157 (3.2%) | 5 | 1/57 (1.8%) | 2 | 4/45 (8.9%) | 4 | 5/119 (4.2%) | 5 |
| Upper respiratory tract infection | 10/372 (2.7%) | 10 | 8/157 (5.1%) | 8 | 2/57 (3.5%) | 2 | 1/45 (2.2%) | 1 | 5/119 (4.2%) | 5 |
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 18/372 (4.8%) | 18 | 5/157 (3.2%) | 5 | 4/57 (7%) | 4 | 0/45 (0%) | 0 | 1/119 (0.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 5/372 (1.3%) | 6 | 3/157 (1.9%) | 5 | 3/57 (5.3%) | 3 | 2/45 (4.4%) | 2 | 2/119 (1.7%) | 2 |
| Back pain | 10/372 (2.7%) | 13 | 4/157 (2.5%) | 4 | 3/57 (5.3%) | 3 | 1/45 (2.2%) | 1 | 2/119 (1.7%) | 2 |
| Nervous system disorders | ||||||||||
| Dizziness | 23/372 (6.2%) | 26 | 4/157 (2.5%) | 4 | 1/57 (1.8%) | 1 | 5/45 (11.1%) | 5 | 7/119 (5.9%) | 7 |
| Headache | 55/372 (14.8%) | 62 | 16/157 (10.2%) | 18 | 8/57 (14%) | 11 | 6/45 (13.3%) | 6 | 16/119 (13.4%) | 19 |
| Somnolence | 27/372 (7.3%) | 27 | 11/157 (7%) | 11 | 2/57 (3.5%) | 2 | 3/45 (6.7%) | 3 | 3/119 (2.5%) | 3 |
| Psychiatric disorders | ||||||||||
| Anorgasmia | 4/372 (1.1%) | 4 | 3/157 (1.9%) | 3 | 1/57 (1.8%) | 1 | 3/45 (6.7%) | 3 | 0/119 (0%) | 0 |
| Insomnia | 25/372 (6.7%) | 25 | 3/157 (1.9%) | 3 | 8/57 (14%) | 9 | 3/45 (6.7%) | 3 | 4/119 (3.4%) | 4 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Hyperhidrosis | 12/372 (3.2%) | 13 | 1/157 (0.6%) | 1 | 3/57 (5.3%) | 3 | 3/45 (6.7%) | 3 | 6/119 (5%) | 6 |
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 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00666757
Other Study ID Numbers:
- 11715
- F1J-US-HMFT
First Posted:
Apr 25, 2008
Last Update Posted:
Jun 15, 2010
Last Verified:
May 1, 2010