A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 22
- 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
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia
详细描述
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).
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
- •Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
- •The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
- •If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
排除标准
- •The patient has used an investigational drug within the past 30 days
- •The patient has participated in a previous study of this compound
研究组 & 干预措施
Lurasidone
80 mg AM dosing once daily
干预措施: Lurasidone (Drug)
Placebo
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.
次要结局
- Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores(Baseline and 6 weeks)
- 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)