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
- 试验地点
- 18
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
This is a multinational, multicenter randomized, double-blind, placebo-controlled, parallel-group, fixed/flexible dose study to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder. The study will be a total of 6 weeks in duration: a no-drug screening period of up to 4 to 7 days, followed by 3 weeks of double-blind treatment and a 2-week safety follow-up period. The primary outcome measure is the YMRS and the secondary outcome measure is the CGI-S. This study will be performed at approximately 40 study centers located in and outside the United States. Globally the enrollment target is 320 patients. In India the enrollment target is 160 patients. The date of first patient enrollment in India is March 23, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: 3 Weeks
次要结局
- Clinical Global Impression-Severity (CGI-S)(3 Weeks)