NCT00432614已完成3 期
A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d
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
- 510
- 试验地点
- 1
- 主要终点
- Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
研究概览
简要总结
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
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
- •Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30
排除标准
- •Patient is at immediate risk for suicidal behavior
- •Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- •Patients with a current depressive episode secondary to a general medical disorder
- •Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
- •Patients with severe or unstable concomitant medical conditions
- •Pregnant, breastfeeding, or likely to become pregnant during the study
- •Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
研究组 & 干预措施
Group 1
Experimental
SR58611A 350mg twice daily with escitalopram 10mg once daily
干预措施: SR58611A (Drug)
Group 1
Experimental
SR58611A 350mg twice daily with escitalopram 10mg once daily
干预措施: escitalopram (Drug)
Group 2
Active Comparator
placebo with escitalopram 10mg once daily
干预措施: escitalopram (Drug)
Group 3
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
时间窗: 8 weeks
次要结局
- Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score(8 weeks)
研究者
研究点 (1)
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