EUCTR2012-002705-21-CZ进行中（未招募）1 期
Interventional, open-label, flexible-dose extension study ofbrexpiprazole in patients with schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- •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.
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
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.
研究者
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