A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 27
- 主要终点
- Time to Relapse of Psychotic Symptoms During 6 Weeks
研究概览
简要总结
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ≥ 18 years of age.
- •Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
- •Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
排除标准
- •Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
- •Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
- •Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
研究组 & 干预措施
Lurasidone Open-Label Arm A
干预措施: Lurasidone HCl (Drug)
Lurasidone Open-Label Arm B
干预措施: Lurasidone HCl (Drug)
Lurasidone Open-Label Arm C
干预措施: Lurasidone HCl (Drug)
结局指标
主要结局
Time to Relapse of Psychotic Symptoms During 6 Weeks
时间窗: 6 Weeks
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
次要结局
- Tolerability and Safety(6 Weeks)