A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 617
- 试验地点
- 58
- 主要终点
- Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided informed consent prior to any study specific procedures
- •Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
- •Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
- •Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
- •Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- •CGI-S score ≥ 4
排除标准
- •Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- •Bipolar I and II disorder
- •Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- •DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- •Women who are pregnant or breast feeding
研究组 & 干预措施
Cariprazine 3mg
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
干预措施: Cariprazine (Drug)
Cariprazine 6mg
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
干预措施: Cariprazine (Drug)
Aripiprazole 10mg
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
干预措施: Aripiprazole (Drug)
Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
干预措施: Placebo (Drug)
结局指标
主要结局
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
时间窗: Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
次要结局
- Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)(Baseline to Week 6)