INTERVENTIONALACTIVE NOT RECRUITINGNCT04105231

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-01-27

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 64 (ESTIMATED)
Start date: 2021-06-01
Sponsor: Lone Baandrup
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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 to schizophrenia. It is the THC (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the CBD content has potential therapeutic effects. This trial investigates treatment with CBD (without THC) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. We hypothesize that CBD will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. Sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how CBD affects objective and subjective sleep quality as well as circadian rest-activity cycles. Based on previous studies investigating CBD as monotherapy in patients with schizophrenia, it is expected that CBD will be associated with fewer adverse events than risperidone.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol

Medicines

EPIDIOLEX Epidiolex

Research network

Researchers and organizations

Birte Glenthøj Jesper Østrup Rasmussen Kristian Linnet Lone Baandrup Poul Jennum Glostrup Hospital Rigshospitalet University of Copenhagen

Interventions

What was registered

DRUG

Cannabidiol

Cannabidiol oral suspension

Epidiolex

DRUG

Risperidone

Risperidone, encapsulated tablet.

Risperidon

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Not accepted

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 outcomes

primary measures

Psychotic symptoms

Time frame: 7 weeks follow-up

Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.

secondary outcomes

secondary measures

Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)

Time frame: 7 weeks follow-up

Timeline follow back method

Cannabis use by self-reported days of cannabis use per week, since last study visit.

Time frame: 7 weeks follow-up

Timeline follow back method

Amount of cannabis use per day, self-reported, since last study visit.

Time frame: 7 weeks follow-up

PSYSCAN cannabis questionnaire# 6-8

Response

Time frame: 7 weeks follow-up

Response defined by PANSS total 25 percentile changes

Remission

Time frame: 7 weeks follow-up

Symptomatic remission is defined according to the Andreasen et al remission criteria. The criteria define symptomatic remission as a rating of no more than mild in four core positive and four core negative symptoms on the Positive and Negative Syndrome Scale (P1, P2 P3, N1, N4, N6, G5, G9,) that is sustained for ≥6 months. Because of the duration of this study, the requirement of 6 month will not be considered.

Global illness severity

Time frame: 7 weeks follow-up

Global illness severity is assessed with the Clinical Global Impression Scale (CGI). We will use the severity (CGI-S) at baseline and improvement (CGI-I) scores of the CGI at the following visits. Response will be defined as much improved or better on the CGI-I. The main item 'severity of illness' is measured on a 7-point Likert scale (from 1 'normal, not at all ill' to 7 'among the most extremely ill patients').

Psychosocial functioning

Time frame: 7 weeks follow-up

Personal and Social Performance Scale (PSP). Higher is better, range 1-100.

Neurocognitive functioning

Time frame: 7 weeks follow-up

Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales.

Subjective well-being

Time frame: 7 weeks follow-up

Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life.

other outcomes

other measures

Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs)

Time frame: From baseline to 2 weeks after end of treatment

Self-report

Extrapyramidal and other side effects

Time frame: 7 weeks follow-up

Udvalget for Kliniske Undersoegelser (UKU) short version A clinician-rated scale to assess antipsychotic side effects

Publications

Locally readable linked articles

linked publication

Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial.

BMC Psychiatry · Free full text

Snapshot provenance

Snapshot: 9a4940ac-c252-43bf-a81e-a7dd1476a683
Retrieved: 11/09/2026, 14:16:35
SHA-256: 48b2eb61a43cbc8667e6c145e6888ec9011b285f29dd6e972e0b54faf29fccba

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

Researchers and organizations

What was registered

Cannabidiol

Risperidone

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Psychotic symptoms

secondary measures

Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)

Cannabis use by self-reported days of cannabis use per week, since last study visit.

Amount of cannabis use per day, self-reported, since last study visit.

Response

Remission

Global illness severity

Psychosocial functioning

Neurocognitive functioning

Subjective well-being

other measures

Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs)

Extrapyramidal and other side effects

Locally readable linked articles

Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial.

Circadian rest-activity cycle

Subjective sleep quality

Objective sleep evaluation

Metabolomics