Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 4
- 主要终点
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
研究概览
简要总结
The study evaluates the efficacy and safety of SM-13496 compared with placebo 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meets DSM-IV-TR criteria for schizophrenia.
- •Patient is aged 18 through 74 years at informed consent.
- •Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
排除标准
- •Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- •Patient has Parkinson's disease.
- •Patient has a history or complication of malignancy.
研究组 & 干预措施
SM-13496 80mg
干预措施: SM-13496 80mg (Drug)
SM-13496 40mg
干预措施: SM-13496 40mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
时间窗: Baseline and 6 week
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
次要结局
- Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6(Baseline and 6 weeks)
- Change From Baseline in PANSS Positive Subscale Scores at Week 6(Baseline and 6 weeks)
- Change From Baseline in PANSS Negative Subscale Scores at Week 6(Baseline and 6 weeks)
- Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)(From Baseline to 6 weeks)
- Proportion of Participants With TEAEs Leading to Discontinuation(From Baseline to 6 weeks)
- Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6(Baseline and 6 weeks)
- Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)(From Baseline to 6 weeks)