Cannabidiol for treatment of non-affective psychosis and cannabis use

Phase 2/3

Not yet recruiting

• Conditions: Lifetime cannabis use; Non-affective psychosis

• Registration Number: 2024-517630-18-00
• Lead Sponsor: Region Hovedstaden

Brief Summary

To examine the efficacy of cannabidiol (CBD) for treatment of psychosis

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-08
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 64

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of psychotic symptoms		Severity of psychotic symptoms

Secondary Outcome Measures

Name	Time	Method
Frequency and quantity of cannabis use by self-reported days of cannabis use per week and amount of use		Frequency and quantity of cannabis use by self-reported days of cannabis use per week and amount of use
Cannabis cessation (for current users), defined as no use during the past two weeks (self-reported)		Cannabis cessation (for current users), defined as no use during the past two weeks (self-reported)
Total symptom severity		Total symptom severity
Symptom response and remission		Symptom response and remission
Global severity of illness		Global severity of illness
Psychosocial functioning		Psychosocial functioning
Neurocognitive functioning		Neurocognitive functioning
Subjective well-being		Subjective well-being
Circadian sleep-wake cycle		Circadian sleep-wake cycle
Subjective sleep quality		Subjective sleep quality
Objective sleep evaluation		Objective sleep evaluation
Metabolomics		Metabolomics

Trial Locations

Locations (1)

Psykiatrisk Center Kobenhavn; 🇩🇰 Copenhagen Nv, Denmark

Psykiatrisk Center Kobenhavn

🇩🇰Copenhagen Nv, Denmark

Lone Baandrup

Site contact

91165903

lone.baandrup@regionh.dk