A randomized, double-blind, placebo-controlled, parallel-group study of Cariprazine (RGH-188) in the prevention of relapse in patients with schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 15
- 主要终点
- Time from baseline to the first symptom relapse during the Double-Blind phase
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel-group study of Cariprazine (RGH-188) in the prevention of relapse in patients with schizophrenia xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia.
The primary outcome measures will be time from baseline to the first symptom relapse during the Double-Blind phase.
Globally, this study is proposed to be conducted in 09 countries including USA, Ukraine, Bulgaria, Argentina, Romania, Slovakia and India.
We propose to conduct the referenced study on 270 enrolled subjects and 54 randomized subjects at 22 study centers in India, out of 900 planned subjects to be screened, approximately 450 will be enrolled in the open-label Run-In Phase; with approximately 180 randomized patients during the Double-Blind Phase globally.
The tentative date of enrollment of first patient in India is April 01, 2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •â€¢Patients who have provided informed consent prior to any study specific procedures •Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria as determined by the Structured Clinical Interview for DSM-IV (SCID) •Patients with normal physical examination, laboratory, vital signs, and/ or ECG •Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 •PANSS total score greater than or equal to 70 and less than or equal to 120 at Visit 1 and Visit 2 •Negative serum B-human chorionic Gonadotropin (B-hCG) pregnancy test (applies to female patients of childbearing potential only) •Body mass index between 18 and 40kg/m2, inclusive.
排除标准
- •â€¢Patients currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorders •Patients in their first episode of Psychosis •Treatment-resistant schizophrenia over the last 2 years •Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication •At imminent risk of injuring self or others or causing significant damage to property •Suicide risk.
结局指标
主要结局
Time from baseline to the first symptom relapse during the Double-Blind phase
时间窗: At 20 Weeks and Bi-Weekly thereafter until week 92
次要结局
- Time from baseline to the first symptom relapse during the Double-Blind phase(At 20 Weeks and Bi-Weekly thereafter until week 92)