NCT00088621已完成2 期
An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 19
- 主要终点
- Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
研究概览
简要总结
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
详细描述
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lurasidone 80 mg tablet
Experimental
Lurasidone 80mg oral tablet taken once a day
干预措施: Lurasidone 80mg tablet (Drug)
结局指标
主要结局
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (19)
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