NCT01485640已完成3 期
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
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
- 162
- 试验地点
- 46
- 主要终点
- Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
研究概览
简要总结
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
- •The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
- •The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
- •The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
排除标准
- •The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
- •The subject resides in a country where lurasidone has been approved for any indication.
- •The subject is currently enrolled in any other investigational study.
- •The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
研究组 & 干预措施
Lurasidone
Experimental
Lurasidone flexibly dosed
干预措施: Lurasidone (Drug)
结局指标
主要结局
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
时间窗: 18 months
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
次要结局
- Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S(18 months)
研究者
研究点 (46)
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