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

Optimization of Treatment and Management of Schizophrenia in Europe - OPTiMiSE

niversity Medical Centre Utrecht0 个研究点目标入组 446 人开始时间: 2010年12月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
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

  • i) 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), a short diagnostic structured interview.
  • ii) Age 18-40 years
  • iii) Written informed consent
  • iv) Mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).
  • For all participants at UK site:
  • iii) Adequate command of English to understand the study and complete the assessments
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • i) A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
  • ii) Prior use of antipsychotic medication for longer than an episode of two weeks in the previous year and/or 6 weeks during lifetime.
  • iii) Intolerance to one of the drugs in this study.
  • iv) The presence of one or more of the contraindications against any of the study drugs
  • vi) Pregnancy, as determined through a pregnancy test, or lactation
  • vii) Lack of mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).
  • For participation in MRI scans only (if they meet this exclusion criteria, they can still participate in the rest of the study)
  • i) any contraindication to imaging e.g. implanted metallic objects or electronic devices

研究者

发起方
niversity Medical Centre Utrecht

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