Status:
RECRUITING
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
Lead Sponsor:
Lone Baandrup
Collaborating Sponsors:
Danish Center for Sleep Medicine
Copenhagen University Hospital, Denmark
Conditions:
Dual Diagnosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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 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
- 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 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
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04105231
Start Date
June 1 2021
End Date
June 1 2025
Last Update
December 12 2024
Active Locations (1)
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1
Center for Neuropsychiatric Schizophrenia Research
Glostrup Municipality, Denmark, 2600