A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)

TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode

The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: duloxetine; Drug: citalopram; Drug: fluoxetine; Drug: paroxetine; Drug: sertraline

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Carson, California, United States, 90746
      • 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
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    • San Diego, California, United States, 92108
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    • Sherman Oaks, California, United States, 91403
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    • Torrance, California, United States, 90502
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  • Colorado
    • Pueblo, Colorado, United States, 81008
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  • Florida
    • Clearwater, Florida, United States, 33765
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    • Coral Springs, Florida, United States, 33065
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    • Deerfield Beach, Florida, United States, 33064
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    • Fort Myers, Florida, United States, 33912
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    • Gainesville, Florida, United States, 32607
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    • Hialeah, Florida, United States, 33016
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    • Melbourne, Florida, United States, 32901
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    • Miami, Florida, United States, 33173
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    • Winter Park, Florida, United States, 32789
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  • Georgia
    • Atlanta, Georgia, United States, 30338
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  • Illinois
    • Joliet, Illinois, United States, 60435
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    • Oak Brook, Illinois, United States, 60523
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    • Park Ridge, Illinois, United States, 60068
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  • Indiana
    • Greenwood, Indiana, United States, 46143
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    • Terre Haute, Indiana, United States, 47802
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  • Kansas
    • Prairie Village, Kansas, United States, 66206
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    • Wichita, Kansas, United States, 67203
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  • Maryland
    • Gaithersburg, Maryland, United States, 20877
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    • Glen Burnie, Maryland, United States, 21061
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    • Rockville, Maryland, United States, 20852
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  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
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  • Missouri
    • St Louis, Missouri, United States, 63141
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  • New Jersey
    • Clementon, New Jersey, United States, 08021
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    • Princeton, New Jersey, United States, 08540
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  • New York
    • Brooklyn, New York, United States, 11223
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    • Fresh Meadows, New York, United States, 11366
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    • Mount Kisco, New York, United States, 10549
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    • Rochester, New York, United States, 14618
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    • Staten Island, New York, United States, 10312
      • 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.
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • 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
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  • Ohio
    • Beachwood, Ohio, United States, 44122
      • 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
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    • Kettering, Ohio, United States, 45429
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73119
      • 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.
  • Oregon
    • Eugene, Oregon, United States, 97404
      • 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.
  • Pennsylvania
    • Havertown, Pennsylvania, United States, 19083
      • 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
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    • Newtown, Pennsylvania, United States, 18940
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    • Philadelphia, Pennsylvania, United States, 19139
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  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • 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.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • 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.
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • 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.
  • Texas
    • Austin, Texas, United States, 78756
      • 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
      • 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
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    • Houston, Texas, United States, 77074
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    • Lake Jackson, Texas, United States, 77566
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    • San Antonio, Texas, United States, 78229
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    • Wichita Falls, Texas, United States, 76309
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  • Vermont
    • Woodstock, Vermont, United States, 05091
      • 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.
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • 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
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  • Washington
    • Bellevue, Washington, United States, 98004
      • 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.
  • Wisconsin
    • Brown Deer, Wisconsin, United States, 53223
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: paroxetine	Drug: paroxetine; 20-50 mgs orally daily for 12 weeks
Active Comparator: fluoxetine	Drug: fluoxetine; 20-80 mgs orally daily for 12 weeks
Experimental: duloxetine; study drug	Drug: duloxetine; 30-120 milligrams (mgs) orally daily for 12 weeks; Other Names: Cymbalta; LY248686
Active Comparator: citalopram	Drug: citalopram; 20-40 mgs orally daily for 12 weeks
Active Comparator: sertraline	Drug: sertraline; 50-200 mgs orally daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)	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.	Baseline, 12 weeks
Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]	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.	12 weeks
Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]	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.	Baseline, 12-Weeks
Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]	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.	Baseline, 12-Weeks
Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)	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).	Baseline, 12 Weeks
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)	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.	Baseline, 12 Weeks
Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)	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).	Baseline, 12 weeks
Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)	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).	Baseline, 12 Weeks
Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)	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).	Baseline, 12 Weeks
Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)	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).	Baseline, 12 Weeks
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)	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.	Baseline, 12 Weeks
Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)	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.	Baseline, 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)	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.	Baseline, 12 weeks
Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)	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.	Baseline, 12 Weeks
Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)	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.	Baseline, 12 Weeks
Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)	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.	Baseline, 12 Weeks
Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint	Mean change from baseline to endpoint in systolic blood pressure	Baseline, 12 Weeks
Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint	Mean change from baseline to endpoint in diastolic blood pressure	Baseline, 12 Weeks
Change From Baseline in Pulse Rate at Week-12 Endpoint	Mean change from baseline to endpoint in pulse rate	Baseline, 12 Weeks
Change From Baseline in Weight at Week-12 Endpoint	Mean change from baseline to endpoint in weight	Baseline, 12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 12 Weeks
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	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.	Baseline, 12 weeks
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint	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.	Baseline, 12 Weeks
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint	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.	Baseline, 12 Weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: 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

Publications and helpful links

General Publications

• Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
• Martinez JM, Katon W, Greist JH, Kroenke K, Thase ME, Meyers AL, Edwards SE, Marangell LB, Shoemaker S, Swindle R. A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode. Int Clin Psychopharmacol. 2012 Jan;27(1):17-26. doi: 10.1097/YIC.0b013e32834ce11b.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (Estimate): April 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: May 12, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Severe Depressive Episode
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Sertraline; Duloxetine Hydrochloride; Citalopram; Paroxetine; Fluoxetine
• Other Study ID Numbers: 11715 (DAIDS ES); F1J-US-HMFT (Other Identifier: Eli Lilly and Company)