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临床试验/EUCTR2010-020185-19-BE
EUCTR2010-020185-19-BE进行中(未招募)1 期

Optimization of Treatment and Management of Schizophrenia in Europe - the optimise trial

niversity Medical Center Utrecht0 个研究点目标入组 446 人开始时间: 2011年8月10日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
446

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

  • Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder as defined by DSM-IV on the basis of the Mini International Neuropsychiatric Interview Plus (M.I.N.I. Plus; Sheehan et al. 1998).
  • Age 18-40 years
  • Written informed consent.
  • 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 350
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
  • Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.
  • Intolerance to one of the drugs in this study.
  • Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
  • Patients who are represented by a legal ward or under legal custody
  • The presence of one or more of the contraindications against any of the study drugs as mentioned in the IB texts
  • Pregnancy or lactation

研究者

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