NCT00345098已完成3 期
A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12)
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
- 704
- 试验地点
- 13
- 主要终点
- The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
研究概览
简要总结
The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI)
- •Total score on the Montgomery and Asberg Depression Rating Scale (MADRS) > 28
- •At W12 (V7), patients will be randomized into the double-blind treatment phase if they have MADRS total score < 12
排除标准
- •Patients with a significant risk of suicide.
- •Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum 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
- •Patients with clinically significant abnormal laboratory value at screening
- •The investigator will evaluate whether there are other reasons why a patient may not participate
结局指标
主要结局
The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
次要结局
- Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score
研究者
研究点 (13)
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