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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Center for Neuropsychiatric Schizophrenia Research
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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