EUCTR2008-007483-42-SK进行中（未招募）1 期
A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depression
Sunovion, Inc.0 个研究点目标入组 196 人开始时间: 2010年11月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject has agreed to participate by providing written informed consent
- •Subject has completed 6 weeks of treatment in Studies D1050235, D1050236 or
- •Subject is judged by the investigator to be suitable for participation in a clinical trial
- •involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at baseline (Visit 8 in either studies D1050235, D1050236 or D1050292).
- •Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property
研究者
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