A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)
2010년 5월 12일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
750
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Carson, California, 미국, 90746
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Irvine, California, 미국, 92618
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San Diego, California, 미국, 92108
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Sherman Oaks, California, 미국, 91403
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Torrance, California, 미국, 90502
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Colorado
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Pueblo, Colorado, 미국, 81008
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Florida
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Clearwater, Florida, 미국, 33765
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Coral Springs, Florida, 미국, 33065
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Deerfield Beach, Florida, 미국, 33064
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Fort Myers, Florida, 미국, 33912
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Gainesville, Florida, 미국, 32607
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Hialeah, Florida, 미국, 33016
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Melbourne, Florida, 미국, 32901
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Miami, Florida, 미국, 33173
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Winter Park, Florida, 미국, 32789
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Georgia
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Atlanta, Georgia, 미국, 30338
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Illinois
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Joliet, Illinois, 미국, 60435
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Oak Brook, Illinois, 미국, 60523
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Park Ridge, Illinois, 미국, 60068
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Indiana
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Greenwood, Indiana, 미국, 46143
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Terre Haute, Indiana, 미국, 47802
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Kansas
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Prairie Village, Kansas, 미국, 66206
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Wichita, Kansas, 미국, 67203
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Maryland
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Gaithersburg, Maryland, 미국, 20877
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Glen Burnie, Maryland, 미국, 21061
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Rockville, Maryland, 미국, 20852
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Massachusetts
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Fall River, Massachusetts, 미국, 02721
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Missouri
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St Louis, Missouri, 미국, 63141
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New Jersey
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Clementon, New Jersey, 미국, 08021
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Princeton, New Jersey, 미국, 08540
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New York
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Brooklyn, New York, 미국, 11223
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Fresh Meadows, New York, 미국, 11366
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Mount Kisco, New York, 미국, 10549
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Rochester, New York, 미국, 14618
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Staten Island, New York, 미국, 10312
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North Carolina
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Concord, North Carolina, 미국, 28025
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Durham, North Carolina, 미국, 27707
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Ohio
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Beachwood, Ohio, 미국, 44122
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Dayton, Ohio, 미국, 45432
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Kettering, Ohio, 미국, 45429
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73119
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Oregon
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Eugene, Oregon, 미국, 97404
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Pennsylvania
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Havertown, Pennsylvania, 미국, 19083
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Media, Pennsylvania, 미국, 19063
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Newtown, Pennsylvania, 미국, 18940
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Philadelphia, Pennsylvania, 미국, 19139
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Rhode Island
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Lincoln, Rhode Island, 미국, 02865
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South Carolina
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Columbia, South Carolina, 미국, 29201
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
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Texas
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Austin, Texas, 미국, 78756
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Dallas, Texas, 미국, 75231
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Friendswood, Texas, 미국, 77546
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Houston, Texas, 미국, 77074
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Lake Jackson, Texas, 미국, 77566
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San Antonio, Texas, 미국, 78229
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Wichita Falls, Texas, 미국, 76309
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Vermont
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Woodstock, Vermont, 미국, 05091
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Virginia
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Charlottesville, Virginia, 미국, 22903
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Herndon, Virginia, 미국, 20170
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Washington
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Bellevue, Washington, 미국, 98004
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Wisconsin
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Brown Deer, Wisconsin, 미국, 53223
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 파록세틴
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20-50 mgs orally daily for 12 weeks
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활성 비교기: 플루옥세틴
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20-80 mgs orally daily for 12 weeks
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실험적: duloxetine
study drug
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30-120 milligrams (mgs) orally daily for 12 weeks
다른 이름들:
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활성 비교기: citalopram
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20-40 mgs orally daily for 12 weeks
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활성 비교기: sertraline
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50-200 mgs orally daily for 12 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
기간: 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.
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
기간: Baseline, 12 weeks
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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.
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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]
기간: 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.
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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]
기간: 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.
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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]
기간: Baseline, 12-Weeks
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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.
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Baseline, 12-Weeks
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Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
기간: Baseline, 12 Weeks
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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)
기간: Baseline, 12 Weeks
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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)
기간: Baseline, 12 weeks
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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)
기간: Baseline, 12 Weeks
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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).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
기간: Baseline, 12 Weeks
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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).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
기간: Baseline, 12 Weeks
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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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: Baseline, 12 Weeks
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Mean change from baseline to endpoint in diastolic blood pressure
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Baseline, 12 Weeks
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Change From Baseline in Pulse Rate at Week-12 Endpoint
기간: Baseline, 12 Weeks
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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
기간: Baseline, 12 Weeks
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Mean change from baseline to endpoint in weight
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Baseline, 12 Weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Baseline, 12 Weeks
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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
기간: Baseline, 12 weeks
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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
기간: 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.
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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), Presenteeism Score, at Week-12 Endpoint
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: 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
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 5월 1일
기본 완료 (실제)
2009년 2월 1일
연구 완료 (실제)
2009년 3월 1일
연구 등록 날짜
최초 제출
2008년 4월 23일
QC 기준을 충족하는 최초 제출
2008년 4월 24일
처음 게시됨 (추정)
2008년 4월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 5월 12일
마지막으로 확인됨
2010년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 11715 (DAIDS ES)
- F1J-US-HMFT (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
duloxetine에 대한 임상 시험
-
Yang I. Pachankis완전한