DepressionPhase 4TRY FIRSTNCT00666757
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
A Phase 4 study testing duloxetine, fluoxetine and citalopram in people with Depression, run by Eli Lilly and Company at 61 sites in United States.
Trial summary
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- duloxetine, fluoxetine and citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 61 sitesUnited States
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
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Atlanta, Georgia, 30338
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Austin, Texas, 78756
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Beachwood, Ohio, 44122
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Bellevue, Washington, 98004
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Brooklyn, New York, 11223
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Brown Deer, Wisconsin, 53223
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Carson, California, 90746
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Charlottesville, Virginia, 22903
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Clearwater, Florida, 33765
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Clementon, New Jersey, 08021
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Columbia, South Carolina, 29201
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Concord, North Carolina, 28025
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Coral Springs, Florida, 33065
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Dallas, Texas, 75231
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Dayton, Ohio, 45432
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Deerfield Beach, Florida, 33064
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Durham, North Carolina, 27707
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Eugene, Oregon, 97404
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Fall River, Massachusetts, 02721
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Fort Myers, Florida, 33912
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Fresh Meadows, New York, 11366
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Friendswood, Texas, 77546
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Gainesville, Florida, 32607
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Gaithersburg, Maryland, 20877
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Glen Burnie, Maryland, 21061
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Greenwood, Indiana, 46143
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Havertown, Pennsylvania, 19083
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Herndon, Virginia, 20170
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Hialeah, Florida, 33016
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Houston, Texas, 77074
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Irvine, California, 92618
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Joliet, Illinois, 60435
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Kettering, Ohio, 45429
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Lake Jackson, Texas, 77566
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Lincoln, Rhode Island, 02865
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Media, Pennsylvania, 19063
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Melbourne, Florida, 32901
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Miami, Florida, 33173
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Mount Kisco, New York, 10549
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Newtown, Pennsylvania, 18940
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Oak Brook, Illinois, 60523
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Oklahoma City, Oklahoma, 73119
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Park Ridge, Illinois, 60068
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Philadelphia, Pennsylvania, 19139
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Prairie Village, Kansas, 66206
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Princeton, New Jersey, 08540
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Pueblo, Colorado, 81008
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Rochester, New York, 14618
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Rockville, Maryland, 20852
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San Antonio, Texas, 78229
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San Diego, California, 92108
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Sherman Oaks, California, 91403
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Sioux Falls, South Dakota, 57105
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St Louis, Missouri, 63141
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Staten Island, New York, 10312
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Terre Haute, Indiana, 47802
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Torrance, California, 90502
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Wichita, Kansas, 67203
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Wichita Falls, Texas, 76309
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Winter Park, Florida, 32789
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Woodstock, Vermont, 05091
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- duloxetine, fluoxetine, citalopram, paroxetine, sertraline
- Keywords
- Severe Depressive Episode
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called LY248686, Cymbalta
30-120 milligrams (mgs) orally daily for 12 weeks
fluoxetineDrug
20-80 mgs orally daily for 12 weeks
citalopramDrug
20-40 mgs orally daily for 12 weeks
paroxetineDrug
20-50 mgs orally daily for 12 weeks
sertralineDrug
50-200 mgs orally daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| duloxetine | Experimental | study drug Receives: Drug: duloxetine |
| citalopram | Active comparator | Not described Receives: Drug: citalopram |
| fluoxetine | Active comparator | Not described Receives: Drug: fluoxetine |
| paroxetine | Active comparator | Not described Receives: Drug: paroxetine |
| sertraline | Active comparator | Not described Receives: Drug: sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 Weeks
Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
Mean change from baseline to endpoint in systolic blood pressure
Measured: Baseline, 12 Weeks
Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
Mean change from baseline to endpoint in diastolic blood pressure
Measured: Baseline, 12 Weeks
Change From Baseline in Pulse Rate at Week-12 Endpoint
Mean change from baseline to endpoint in pulse rate
Measured: Baseline, 12 Weeks
Change From Baseline in Weight at Week-12 Endpoint
Mean change from baseline to endpoint in weight
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT-5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666757
- Sponsor's protocol ID
- 11715
- Other IDs
- F1J-US-HMFT
- Acronym
- TRY FIRST
- Status last verified
- May 2010
- First submitted
- 23 Apr 2008
- Last updated
- 15 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 25080392Martinez 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.
PubMed 22027844
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode
- ClinicalTrials.gov ID
- NCT00666757
- Acronym / sponsor ID
- TRY FIRST / 11715
- Conditions
- Depression
- Keywords
- Severe Depressive Episode
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 15 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| duloxetine | Experimental | Drug: duloxetinestudy drug |
| citalopram | Active comparator | Drug: citalopram |
| fluoxetine | Active comparator | Drug: fluoxetine |
| paroxetine | Active comparator | Drug: paroxetine |
| sertraline | Active comparator | Drug: sertraline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetineAlso: LY248686, Cymbalta30-120 milligrams (mgs) orally daily for 12 weeks | Drug | duloxetine |
| fluoxetine20-80 mgs orally daily for 12 weeks | Drug | fluoxetine |
| citalopram20-40 mgs orally daily for 12 weeks | Drug | citalopram |
| paroxetine20-50 mgs orally daily for 12 weeks | Drug | paroxetine |
| sertraline50-200 mgs orally daily for 12 weeks | Drug | sertraline |
Primary outcome
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
Time frame: 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.
20 secondary outcomes
Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: Baseline, 12-Weeks
Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
Time frame: Baseline, 12 weeks
Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
Time frame: 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)
Time frame: Baseline, 12 Weeks
Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
Time frame: Baseline, 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
Time frame: Baseline, 12 weeks
Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
Time frame: Baseline, 12 Weeks
Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
Time frame: Baseline, 12 Weeks
Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
Time frame: Baseline, 12 Weeks
Change From Baseline in Pulse Rate at Week-12 Endpoint
Time frame: Baseline, 12 Weeks
Change From Baseline in Weight at Week-12 Endpoint
Time frame: Baseline, 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25080392Dodd 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.
- Derived from this study: PubMed 22027844Martinez 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT-5 hours, EST) study director
Eli Lilly and Company
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duloxetine, fluoxetine and citalopram in people with Depression, run by Eli Lilly and Company at 61 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2010.