NCT00666757已完成4 期
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
研究概览
简要总结
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
duloxetine
Experimental
study drug
干预措施: duloxetine (Drug)
citalopram
Active Comparator
干预措施: citalopram (Drug)
fluoxetine
Active Comparator
干预措施: fluoxetine (Drug)
paroxetine
Active Comparator
干预措施: paroxetine (Drug)
sertraline
Active Comparator
干预措施: sertraline (Drug)
结局指标
主要结局
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
时间窗: 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.
次要结局
- Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)(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](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](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](Baseline, 12-Weeks)
- Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)(Baseline, 12 Weeks)
- Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)(Baseline, 12 Weeks)
- Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)(Baseline, 12 weeks)
- Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)(Baseline, 12 Weeks)
- Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)(Baseline, 12 Weeks)
- Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)(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)(Baseline, 12 Weeks)
- Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)(Baseline, 12 weeks)
- Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)(Baseline, 12 weeks)
- Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)(Baseline, 12 Weeks)
- Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)(Baseline, 12 Weeks)
- Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)(Baseline, 12 Weeks)
- Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint(Baseline, 12 Weeks)
- Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint(Baseline, 12 Weeks)
- Change From Baseline in Pulse Rate at Week-12 Endpoint(Baseline, 12 Weeks)
- Change From Baseline in Weight at Week-12 Endpoint(Baseline, 12 Weeks)
研究者
研究点 (1)
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