2024-517630-18-00招募中3 期
Cannabidiol for treatment of non-affective psychosis and cannabis use
Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月8日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Severity of psychotic symptoms
研究概览
简要总结
To examine the efficacy of cannabidiol (CBD) for treatment of psychosis
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified nonorganic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5)
- •PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6)
- •Lifetime cannabis use
- •Age 18-45 years
- •Female patients of childbearing potential need to utilize a proper method of contraception
排除标准
- •Treatment resistance as defined by treatment (ever) with clozapine
- •Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2)
- •Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5)
- •Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections)
- •Treatment with an oral antipsychotic within the past 7 days
- •Use of self-administered CBD products during the trial
- •Patients involuntarily admitted
- •Pregnancy or lactation
- •Severe physical illness that might influence the ability to comply with the protocol
结局指标
主要结局
Severity of psychotic symptoms
Severity of psychotic symptoms
次要结局
- Frequency and quantity of cannabis use by self-reported days of cannabis use per week and amount of use
- Cannabis cessation (for current users), defined as no use during the past two weeks (self-reported)
- Total symptom severity
- Symptom response and remission
- Global severity of illness
- Psychosocial functioning
- Neurocognitive functioning
- Subjective well-being
- Circadian sleep-wake cycle
- Subjective sleep quality
- Objective sleep evaluation
- Metabolomics
研究者
Lone Baandrup
Scientific
Psykiatrisk Center Kobenhavn
研究点 (1)
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