NCT01034995已完成2 期
An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 580
- 试验地点
- 73
- 主要终点
- Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
研究概览
简要总结
Primary Objective:
- To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
- To evaluate plasma concentrations of SSR125543
详细描述
This duration of this trial is 11 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（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
SSR125543 20 mg
Experimental
1 capsule of SSR125543 20 mg + 1 capsule of placebo
干预措施: SSR125543 (Drug)
SSR125543 50 mg
Experimental
1 capsule of SSR125543 50 mg + 1 capsule of placebo
干预措施: SSR125543 (Drug)
SSR125543 100 mg
Experimental
2 capsules of SSR125543 50 mg
干预措施: SSR125543 (Drug)
escitalopram 10 mg
Active Comparator
1 capsule of escitalopram 10 mg + 1 capsule of placebo
干预措施: escitalopram (Drug)
placebo
Placebo Comparator
2 capsules of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
时间窗: 8 weeks
次要结局
- Change from baseline in HAM-D depressed mood item(8 weeks)
- Change from baseline in HAM-D responders (50% improvement)(8 weeks)
- Changes from baseline in the HAM-D core and factor scores(8 weeks)
- Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score(8 weeks)
- Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score(8 weeks)
研究者
研究点 (73)
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