NCT00257972已完成3 期
Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
Otsuka Pharmaceutical Development & Commercialization, Inc.89 个研究点 分布在 9 个国家目标入组 400 人开始时间: 2004年10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
- 400
- 试验地点
- 89
- 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 research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bipolar I disorder, manic or mixed episode
排除标准
- •First manic or mixed episode
- •Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- •Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
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 (89)
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