Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
- Registration Number
- NCT04105231
- Lead Sponsor
- Lone Baandrup
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cannabidiol 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. Risperidone 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
- Primary Outcome Measures
Name Time Method Psychotic symptoms 7 weeks follow-up Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.
- Secondary Outcome Measures
Name Time Method Cannabis use by self-reported days of cannabis use per week, since last study visit. 7 weeks follow-up Timeline follow back method
Remission 7 weeks follow-up Symptomatic remission is defined according to the Andreasen et al remission criteria. The criteria define symptomatic remission as a rating of no more than mild in four core positive and four core negative symptoms on the Positive and Negative Syndrome Scale (P1, P2 P3, N1, N4, N6, G5, G9,) that is sustained for ≥6 months. Because of the duration of this study, the requirement of 6 month will not be considered.
Global illness severity 7 weeks follow-up Global illness severity is assessed with the Clinical Global Impression Scale (CGI). We will use the severity (CGI-S) at baseline and improvement (CGI-I) scores of the CGI at the following visits. Response will be defined as much improved or better on the CGI-I. The main item 'severity of illness' is measured on a 7-point Likert scale (from 1 'normal, not at all ill' to 7 'among the most extremely ill patients').
Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline) 7 weeks follow-up Timeline follow back method
Response 7 weeks follow-up Response defined by PANSS total 25 percentile changes
Psychosocial functioning 7 weeks follow-up Personal and Social Performance Scale (PSP). Higher is better, range 1-100.
Subjective well-being 7 weeks follow-up Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life.
Amount of cannabis use per day, self-reported, since last study visit. 7 weeks follow-up PSYSCAN cannabis questionnaire# 6-8
Subjective sleep quality 7 weeks follow-up Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales.
Circadian rest-activity cycle 7 weeks follow-up Actigraphy. A wrist-worne device that measures kinetic energy.
Objective sleep evaluation 7 weeks follow-up Polysomnography (PSG). A measure of objective sleep variables
Neurocognitive functioning 7 weeks follow-up Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales.
Metabolomics 7 weeks follow-up Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood
Trial Locations
- Locations (1)
Center for Neuropsychiatric Schizophrenia Research
🇩🇰Glostrup, Denmark