NCT00094432已完成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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 650 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
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Mean change from baseline to endpoint on the MADRS total score.
研究概览
简要总结
The purpose of this study is to evaluate several doses 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 (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, ages 18-65
- •Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
排除标准
- 未提供
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 on the MADRS total score.
次要结局
- Clinical Global Impression - Bipolar Version
- Severity of illness score depression
- Mean change from baseline to endpoint
研究者
研究点 (1)
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