跳至主要内容
临床试验/EUCTR2012-002705-21-EE
EUCTR2012-002705-21-EE进行中(未招募)不适用

Interventional, open-label, flexible-dose extension study ofbrexpiprazole in patients with schizophrenia

H. Lundbeck A/S0 个研究点目标入组 140 人开始时间: 2013年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140

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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