A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 33
- 主要终点
- Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lurasidone 20 mg
Lurasidone 20 mg tablets
干预措施: Lurasidone 20 mg (Drug)
Lurasidone 40 mg
Lurasidone 40 mg tablets
干预措施: Lurasidone 40mg (Drug)
Lurasidone 80 mg
Lurasidone 2 40 mg tablets
干预措施: Lurasidone 80 mg (Drug)
Haloperidol 10mg
Haloperidol 10mg tablets
干预措施: Haloperidol 10mg (Drug)
Placebo
Matching Placebo to Lurasidone and Haloperidol
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
时间窗: Baseline and 6 weeks
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
次要结局
- Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores(Baseline and 6 weeks)
- Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores(Baseline and 6 weeks)
- Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores(Baseline and 6 weeks)