NCT00429260已完成3 期
A 1-week, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Outpatients With Depression Who Completed 8 Weeks of Treatment With Saredutant 100 mg Once Daily
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
- 125
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.
The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.
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
- •Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria
排除标准
- •Total score of <22 on the Montgomery-Asberg Depression Rating Scale (MADRS).
- •Duration of the current depressive episode is less than 1 month or greater than 2 years.
- •Total score of <25 on the Mini Mental State Examination (elderly patients ≥65 years only).
- •Patients with a history or presence of bipolar disorders or psychotic disorders.
- •Patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.
- •Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
- •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 endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.
次要结局
- The main secondary endpoints are the change from baseline in the maximum number of post-baseline discontinuation-emergent signs or symptoms and the proportions of patients with any newly-occurring post-baseline discontinuation-emergent signs and symptoms
研究者
研究点 (2)
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