NCT00338273撤回3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar 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
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
- •Outpatients
- •Must sign informed consent prior to protocol-related procedures
排除标准
- •Women who are pregnant, trying to become pregnant, or nursing
- •Significant risk of committing suicide
- •Any serious unstable medical conditions
研究组 & 干预措施
A1
Active Comparator
干预措施: Aripiprazole (Drug)
A2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
次要结局
- Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)
研究者
研究点 (1)
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