NCT00825058已完成3 期
A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- change from baseline of the total score of the HAM-D 17 items.
研究概览
简要总结
Primary objective :
- To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.
Secondary objectives:
- To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
- •patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
- •the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration
排除标准
- 未提供
研究组 & 干预措施
2
Placebo Comparator
干预措施: placebo (Drug)
1
Experimental
干预措施: amibegron (SR58611A) (Drug)
3
Active Comparator
干预措施: paroxetine (Drug)
结局指标
主要结局
change from baseline of the total score of the HAM-D 17 items.
时间窗: 6 weeks
次要结局
- HAM-D subscores(6 weeks)
- HAM-D responders and remitters(6 weeks)
- HAM-A total score and subscores(6 weeks)
- MADRS total score(6 weeks)
- clinical global impression (CGI) severity and improvement scores(6 weeks)
- patient global impression (PGI) improvement score(6 weeks)
- social and occupational functioning assessment scale (SOFAS) score(6 weeks)
- clinical monitoring of adverse events (AEs)(6 weeks)
- laboratory parameters(6 weeks)
- electrocardiogram (ECG) parameters, change in vital signs and body weight(6 weeks)
研究者
研究点 (1)
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