NCT01810783已完成3 期
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
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
- 210
- 试验地点
- 48
- 主要终点
- Safety and Tolerability
研究概览
简要总结
To determine the safety and efficacy of brexpiprazole during long-term treatment.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has completed the lead-in study 14644A.
- •The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
- •The patient agrees to protocol-defined use of effective contraception.
排除标准
- •The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
- •The patient has a clinically significant unstable illness diagnosed during Study 14644A.
- •The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- •The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
- •The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Brexpiprazole
Experimental
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)
Number of treatment-emergent adverse events (TEAEs)
次要结局
未报告次要终点
研究者
研究点 (48)
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