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Clinical Trials in Denmark / NCT04105231
Active, not recruiting Phase 2

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

NCT04105231 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2021-06-01
Last updated
2026-01-27

Condition(s) studied

Dual Diagnosis

Investigational drug(s) / intervention(s)

Cannabidiol →Risperidone →

Cannabidiol: Cannabidiol oral suspension

Risperidone: Risperidone, encapsulated tablet.

Study 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.

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)

Trial sites (1)

FacilityCityRegionStatus
Center for Neuropsychiatric Schizophrenia Research Glostrup Municipality Denmark

More Lone Baandrup trials in Denmark

Other trials for the same condition

Official registry record

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.

View NCT04105231 on ClinicalTrials.gov ↗ ← All trials in Denmark