A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)
2010年5月12日 更新者：Eli Lilly and Company
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.
研究概览
研究类型
介入性
注册 (实际的)
750
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Carson、California、美国、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.
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Irvine、California、美国、92618
- 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.
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San Diego、California、美国、92108
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Sherman Oaks、California、美国、91403
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Torrance、California、美国、90502
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Colorado
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Pueblo、Colorado、美国、81008
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Florida
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Clearwater、Florida、美国、33765
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Coral Springs、Florida、美国、33065
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Deerfield Beach、Florida、美国、33064
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Fort Myers、Florida、美国、33912
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Gainesville、Florida、美国、32607
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Hialeah、Florida、美国、33016
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Melbourne、Florida、美国、32901
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Miami、Florida、美国、33173
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Winter Park、Florida、美国、32789
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Georgia
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Atlanta、Georgia、美国、30338
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Illinois
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Joliet、Illinois、美国、60435
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Oak Brook、Illinois、美国、60523
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Park Ridge、Illinois、美国、60068
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Indiana
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Greenwood、Indiana、美国、46143
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Terre Haute、Indiana、美国、47802
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Kansas
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Prairie Village、Kansas、美国、66206
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Wichita、Kansas、美国、67203
- 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.
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Maryland
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Gaithersburg、Maryland、美国、20877
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Glen Burnie、Maryland、美国、21061
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Rockville、Maryland、美国、20852
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Massachusetts
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Fall River、Massachusetts、美国、02721
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Missouri
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St Louis、Missouri、美国、63141
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New Jersey
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Clementon、New Jersey、美国、08021
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Princeton、New Jersey、美国、08540
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New York
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Brooklyn、New York、美国、11223
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Fresh Meadows、New York、美国、11366
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Mount Kisco、New York、美国、10549
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Rochester、New York、美国、14618
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Staten Island、New York、美国、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.
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North Carolina
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Concord、North Carolina、美国、28025
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Durham、North Carolina、美国、27707
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Ohio
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Beachwood、Ohio、美国、44122
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Dayton、Ohio、美国、45432
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Kettering、Ohio、美国、45429
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Oklahoma
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Oklahoma City、Oklahoma、美国、73119
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Oregon
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Eugene、Oregon、美国、97404
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Pennsylvania
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Havertown、Pennsylvania、美国、19083
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Media、Pennsylvania、美国、19063
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Newtown、Pennsylvania、美国、18940
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Philadelphia、Pennsylvania、美国、19139
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Rhode Island
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Lincoln、Rhode Island、美国、02865
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South Carolina
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Columbia、South Carolina、美国、29201
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South Dakota
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Sioux Falls、South Dakota、美国、57105
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Texas
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Austin、Texas、美国、78756
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Dallas、Texas、美国、75231
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Friendswood、Texas、美国、77546
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Houston、Texas、美国、77074
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Lake Jackson、Texas、美国、77566
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San Antonio、Texas、美国、78229
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Wichita Falls、Texas、美国、76309
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Vermont
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Woodstock、Vermont、美国、05091
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Virginia
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Charlottesville、Virginia、美国、22903
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Herndon、Virginia、美国、20170
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Washington
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Bellevue、Washington、美国、98004
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Wisconsin
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Brown Deer、Wisconsin、美国、53223
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：帕罗西汀
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20-50 mgs orally daily for 12 weeks
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有源比较器：氟西汀
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20-80 mgs orally daily for 12 weeks
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实验性的：duloxetine
study drug
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30-120 milligrams (mgs) orally daily for 12 weeks
其他名称：
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有源比较器：citalopram
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20-40 mgs orally daily for 12 weeks
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有源比较器：sertraline
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50-200 mgs orally daily for 12 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
大体时间：12 weeks
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
大体时间：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.
|
Baseline, 12 weeks
|
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Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]
大体时间：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.
|
12 weeks
|
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Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
大体时间：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.
|
Baseline, 12-Weeks
|
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Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
大体时间：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.
|
Baseline, 12-Weeks
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Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
大体时间：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).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
大体时间：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.
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Baseline, 12 Weeks
|
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Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
大体时间：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).
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Baseline, 12 weeks
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Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
大体时间：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).
|
Baseline, 12 Weeks
|
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Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
大体时间：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).
|
Baseline, 12 Weeks
|
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Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
大体时间：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).
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Baseline, 12 Weeks
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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)
大体时间：Baseline, 12 Weeks
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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.
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Baseline, 12 Weeks
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Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
大体时间：Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
大体时间：Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
大体时间：Baseline, 12 Weeks
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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.
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Baseline, 12 Weeks
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Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
大体时间：Baseline, 12 Weeks
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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.
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Baseline, 12 Weeks
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Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
大体时间：Baseline, 12 Weeks
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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.
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Baseline, 12 Weeks
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Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
大体时间：Baseline, 12 Weeks
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Mean change from baseline to endpoint in systolic blood pressure
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Baseline, 12 Weeks
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Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
大体时间：Baseline, 12 Weeks
|
Mean change from baseline to endpoint in diastolic blood pressure
|
Baseline, 12 Weeks
|
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Change From Baseline in Pulse Rate at Week-12 Endpoint
大体时间：Baseline, 12 Weeks
|
Mean change from baseline to endpoint in pulse rate
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Baseline, 12 Weeks
|
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Change From Baseline in Weight at Week-12 Endpoint
大体时间：Baseline, 12 Weeks
|
Mean change from baseline to endpoint in weight
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Baseline, 12 Weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：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.
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Baseline, 12 Weeks
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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
大体时间：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.
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Baseline, 12 weeks
|
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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint
大体时间：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.
|
Baseline, 12 Weeks
|
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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint
大体时间：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.
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Baseline, 12 Weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：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
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年5月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年3月1日
研究注册日期
首次提交
2008年4月23日
首先提交符合 QC 标准的
2008年4月24日
首次发布 (估计)
2008年4月25日
研究记录更新
最后更新发布 (估计)
2010年6月15日
上次提交的符合 QC 标准的更新
2010年5月12日
最后验证
2010年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 11715 (DAIDS ES)
- F1J-US-HMFT (其他标识符：Eli Lilly and Company)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.