NCT00385307已完成3 期
An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD
适应症
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
- 680
- 试验地点
- 2
- 主要终点
- Change from baseline in total score of a depression rating scale at 8 weeks
研究概览
简要总结
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
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
- •Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
- •Patient meets criteria for a recurrent Major Depressive Episode (MDE)
- •Patient meets severity assessments of depression specified by the study
排除标准
- •Patient is at immediate risk for suicidal behavior
- •Patient is with a unstable medical condition
- •Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- •Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
- •Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
- •Patient has been treated with paroxetine (Paxil) within the previous 6 months
- •Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
结局指标
主要结局
Change from baseline in total score of a depression rating scale at 8 weeks
次要结局
- Safety assessments
研究者
研究点 (2)
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