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
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Optimising treatment of patient suffering from schizophrenia in EuropeEUCTR2010-020185-19-BEniversity Medical Center Utrecht446
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不适用
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已完成
3 期
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Optimising treatment of patient suffering from schizophrenia in EuropeSchizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1MedDRA version: 19.0Level: HLTClassification code 10039620Term: Schizoaffective and schizophreniform disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 19.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2010-020185-19-ROniversity Medical Center Utrecht500
