Long-term Extension 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
- 284
- 试验地点
- 4
- 主要终点
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint
研究概览
简要总结
The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who are considered by the investigator eligible for the present study with no significant safety concerns
- •Patients who are fully informed of and understand 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
- •Patients who are planning pregnancy for the expected duration of the study
- •Patients who are otherwise considered ineligible for the study by the investigator
研究组 & 干预措施
SM-13496
干预措施: SM-13496 (Drug)
结局指标
主要结局
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint
时间窗: DB baseline and up to 32 weeks (LOCF endpoint)
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 LOCF Endpoint(DB baseline and up to 32 weeks (LOCF endpoint))
- Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint(DB baseline and up to 32 weeks (LOCF endpoint))
- Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint(DB baseline and up to 32 weeks (LOCF endpoint))
- Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint(DB baseline and up to 32 weeks (LOCF endpoint))
- Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)(EXT baseline and up to 26 weeks)
- Proportion of Participants With TEAEs Leading to Discontinuation(EXT baseline and up to 26 weeks)
- Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)(EXT baseline and up to 26 weeks)