EUCTR2005-005812-25-GR进行中（未招募）1 期
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I Disorder - Protocol R076477-BIM-3002 Phase 3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Man or woman between 18 (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older) and 65 years of age; Meet DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) at the time of screening; History of at least 1 previoulsy documented manic or mixed episode requiring medical treatment within the 3 years before screening phase
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Unable to provide their own consent; Meet DSM-IV criteria other than Bipolar I Disorder; Meet DSM-IV criteria for rapid cycling and schizoaffective disorder; use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening phase; Alcohol intoxication within 3 days before study drug administration on Day 1
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