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临床试验/EUCTR2018-002267-25-CZ
EUCTR2018-002267-25-CZ进行中(未招募)1 期

SAFETY AND EFFICACY OF OLANZAPINE TREATMENT IN PSYCHOSIS: EFFECT OF GENETIC AND EPIGENETIC FACTORS – COVARIATES OF TREATMENT RESPONSE - SEOTP

Fakultní nemocnice Brno0 个研究点目标入组 200 人开始时间: 2018年6月13日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
200

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

  • 1. Dg. F20, F25 according to ICD-10 , treated with olanzapine or initiated treatment by olanzapine
  • 2. Age 18-60 years
  • 3. Signing the 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 200
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Involuntary hospitalization
  • 2. Sui juris restriction or divestiture
  • 3. Olanzapine or caffeine contraindication
  • 4. Pregnancy or breastfeeding
  • 5. Disagreement with the required contraception method(s)
  • 6. Prior participation in any other trial involving investigational medication or medical devices within 14 days prior to the enrolment and during this trial;
  • 7. Other serious medical or psychiatric illness that is not adequately controlled and, in the Investigator’s opinion, would not permit the subject to be managed according to the protocol.

研究者

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