NCT00641745已完成3 期
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 629
- 试验地点
- 69
- 主要终点
- Number of Participants With Adverse Events.
研究概览
简要总结
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to enter the study, each patient must comply with the following inclusion criteria:
- •Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
- •Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
- •Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
- •Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
- •Subject voluntarily agrees to participate in the study by giving written informed consent.
排除标准
- •To be excluded from entering this study if they fulfil any of the criteria below:
- •Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
- •Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
- •In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
- •Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
研究组 & 干预措施
1
Experimental
Lurasidone
干预措施: Lurasidone HCl (Drug)
2
Active Comparator
Risperidone
干预措施: Risperidone (Drug)
结局指标
主要结局
Number of Participants With Adverse Events.
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (69)
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