NCT00095823已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2004年6月最近更新:
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
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Change in a depression rating scale at endpoint
研究概览
简要总结
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.
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
- •Men and women, 18-65 years old
- •Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration.
- •Treatment history of an inadequate response to at least one and no more than three antidepressants.
排除标准
- 未提供
研究组 & 干预措施
A1
Placebo Comparator
干预措施: Antidepressant + Placebo (Drug)
A2
Active Comparator
干预措施: Antidepressant + Aripiprazole (Drug)
结局指标
主要结局
Change in a depression rating scale at endpoint
次要结局
- Change in a disability scale and Clinical Global Impression scale at endpoint
研究者
研究点 (1)
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