Cannabidiol for Treatment of Recent-onset Psychosis With Comorbid Cannabis Use

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial examines the efficacy of cannabidiol (CBD) versus risperidone for treatment of psychosis and cessation of cannabis use in patients with recent-onset psychosis and comorbid cannabis use.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lone Baandrup
• Collaborators: Copenhagen University Hospital, Denmark; Danish Center for Sleep Medicine; Glostrup University Hospital, Copenhagen; University of Copenhagen
• Treatments: Cannabidiol; Epidiolex; Risperidone

Criteria

Inclusion criteria:

• ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified non-organic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5)

• Within the first 5 years after first episode psychosis

• PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6)

• Regular use of cannabis at least on a weekly basis during the last 3 months

• Age 18-64 years

• Female patients of childbearing potential need to utilize a proper method of contraception

Exclusion criteria:

• 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 3 months

• 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