EUCTR2012-004335-23-DK进行中（未招募）1 期
A four-week, multicentre, double-blinded, randomised, active- and placebo-controlled, parallel-group trial investigating efficacy and safety of cannabidiol in acute, early-stage schizophrenic patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
入选标准
- •Informed consent given by the subject
- •DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90) (American Psychiatric Association)
- •Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
- •Age 18 to 65 years, male or female
- •Minimal initial PANSS score of 75 at baseline
- •Female patients of childbearing potential need to utilize a proper method of contraception.
- •Body Mass Index between 18 and 40
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lack of accountability
- •History of treatment-resistant schizophrenia, defined as no re-sponse to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
- •Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- •Serious suicidal risk at screening visit
- •Known intolerance or allergy to olanzapine or cannabidiol
- •Other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia
- •Pregnancy, as determined through a ß-HCG pregnancy test, or lactation
研究者
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