Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Psychotic symptoms
研究概览
简要总结
This trial examines the efficacy of cannabidiol (CBD) versus risperidone for treatment of psychosis in patients with non affective-psychosis and lifetime use of cannabis.
详细描述
People with psychosis and comorbid cannabis use are particularly difficult to treat because cannabis use worsens psychotic symptoms and increases the risk that a first-episode psychosis will progress to schizophrenia. It is the THC (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the CBD content has potential therapeutic effects. This trial investigates treatment with CBD (without THC) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. We hypothesize that CBD will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. Sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how CBD affects objective and subjective sleep quality as well as circadian rest-activity cycles. Based on previous studies investigating CBD as monotherapy in patients with schizophrenia, it is expected that CBD will be associated with fewer adverse events than risperidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 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
研究组 & 干预措施
Cannabidiol
Cannabidiol (Epidiolex®) (oral suspension)100 mg/ml dosed as 3 ml in the morning for 4 days, then increased to 3 ml in the morning and 3 ml in the evening, equivalent to CBD 300 mg BID, with a total treatment duration of 7 weeks.
AND Risperione placebo, encapsulated tablet.
干预措施: Cannabidiol (Drug)
Risperidone
Risperidone (encapsulated tablet) dosed as 2 mg in the morning for 4 days, then increased with 2 mg in the morning and 2 mg in the evening, with a total treatment duration of 7 weeks
AND Cannabidiol placebo, oral suspension
干预措施: Risperidone (Drug)
结局指标
主要结局
Psychotic symptoms
时间窗: 7 weeks follow-up
Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.
次要结局
- Cannabis use by self-reported days of cannabis use per week, since last study visit.(7 weeks follow-up)
- Remission(7 weeks follow-up)
- Global illness severity(7 weeks follow-up)
- Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)(7 weeks follow-up)
- Response(7 weeks follow-up)
- Psychosocial functioning(7 weeks follow-up)
- Subjective well-being(7 weeks follow-up)
- Amount of cannabis use per day, self-reported, since last study visit.(7 weeks follow-up)
- Subjective sleep quality(7 weeks follow-up)
- Circadian rest-activity cycle(7 weeks follow-up)
- Objective sleep evaluation(7 weeks follow-up)
- Neurocognitive functioning(7 weeks follow-up)
- Metabolomics(7 weeks follow-up)
研究者
Lone Baandrup
Head of Clinic
University of Copenhagen