NCT00097266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.1 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2004年12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
- 615
- 试验地点
- 1
- 主要终点
- Change in a mania rating scale at endpoint
研究概览
简要总结
The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
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
- •Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
排除标准
- 未提供
研究组 & 干预措施
A
Placebo Comparator
干预措施: Placebo (Drug)
B
Experimental
干预措施: Aripiprazole (Drug)
C
Active Comparator
干预措施: Haloperidol (Drug)
结局指标
主要结局
Change in a mania rating scale at endpoint
次要结局
- Response rate and Clinical Global Impression scale at endpoint
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed EpisodeBipolar I DisorderNCT00606281Otsuka Pharmaceutical Co., Ltd.258
已完成
4 期
Study of Aripiprazole in Subjects With AlcoholismAlcoholismNCT00082199Otsuka Pharmaceutical Development & Commercialization, Inc.400
已完成
3 期
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's TypeDementia, Alzheimer TypeNCT01438060Otsuka Pharmaceutical Development & Commercialization, Inc.232
已完成
3 期
Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's DisorderTourette's DisorderTic DisorderNCT01727700Otsuka Pharmaceutical Development & Commercialization, Inc.133
已完成
3 期
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's DisorderTourette's DisorderNCT01418339Otsuka Pharmaceutical Development & Commercialization, Inc.135