NCT00095511已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.38 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2004年6月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 38
- 主要终点
- Change from baseline to endpoint in a mania rating scale
研究概览
简要总结
The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Primary diagnosis of Acute Bipolar I Mania
排除标准
- •Patients with a DSM-IV diagnosis other than Bipolar I Mania
结局指标
主要结局
Change from baseline to endpoint in a mania rating scale
次要结局
- Response rate and Clinical Global Impression scale at endpoint
研究者
研究点 (38)
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