CTRI/2010/091/000140已完成3 期
A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •(1) Male or female inpatient, 18 to 65 years of age
- •(2) Patients who have provided informed consent prior to any study specific procedures
- •(3) Patients currently meeting the DSM-IV-TR criteria for bipolar I disorder as confirmed by the SCID, manic or mixed type with or without psychotic symptoms
- •(4) Voluntarily hospitalized for current manic episode
排除标准
- •(1) Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
- •(2) Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/ or ECG
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