Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 732
- 试验地点
- 4
- 主要终点
- Change From Baseline to Week 6 in the PANSS Total Score
研究概览
简要总结
This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with 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
- Double (Participant, Investigator)
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
- •Male or female, 18 to 60 years of age.
- •Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
- •Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤
- •Diagnosis of schizophrenia for at least 1 year.
排除标准
- •Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
- •First episode of psychosis.
研究组 & 干预措施
Placebo
Participants received placebo orally once a day for 6 weeks.
干预措施: Placebo (Drug)
Cariprazine 1.5 mg
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
干预措施: Cariprazine (Drug)
Cariprazine 3.0 mg
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
干预措施: Cariprazine (Drug)
Cariprazine 4.5 mg
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
干预措施: Cariprazine (Drug)
Risperidone 4.0 mg
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in the PANSS Total Score
时间窗: Baseline to Week 6
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
次要结局
- Change From Baseline to Week 6 in the CGI-S Score(Baseline to Week 6)