Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

NCT04105231 | Active Not Recruiting Phase 2

• 2 other identifiers: CBD-P2018-004893-84
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Dual Diagnosis

Keywords

psychosis; cannabis; clinical trial

Outcome Measures

Primary Outcomes (1)

• Psychotic symptoms

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

  7 weeks follow-up

Secondary Outcomes (13)

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

  7 weeks follow-up

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

  7 weeks follow-up

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

  7 weeks follow-up

• Response

  7 weeks follow-up

• Remission

  7 weeks follow-up

Other Outcomes (2)

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

  From baseline to 2 weeks after end of treatment

• Extrapyramidal and other side effects

  7 weeks follow-up

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Cannabidiol (Epidiolex®) (oral suspension)100 mg/ml dosed as 3 ml in the morning for 4 days, then increased to 3 ml in the morning and 3 ml in the evening, equivalent to CBD 300 mg BID, with a total treatment duration of 7 weeks. AND Risperione placebo, encapsulated tablet.

Drug: Cannabidiol

Risperidone

ACTIVE COMPARATOR

Risperidone (encapsulated tablet) dosed as 2 mg in the morning for 4 days, then increased with 2 mg in the morning and 2 mg in the evening, with a total treatment duration of 7 weeks AND Cannabidiol placebo, oral suspension

Drug: Risperidone

Interventions

Cannabidiol DRUG

Cannabidiol oral suspension

Also known as: Epidiolex

Cannabidiol

Risperidone DRUG

Risperidone, encapsulated tablet.

Also known as: Risperidon

Risperidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: collaborator
• University of Copenhagen: collaborator
• Lone Baandrup: lead
• Danish Center for Sleep Medicine: collaborator
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Center for Neuropsychiatric Schizophrenia Research

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Rasmussen JO, Jennum P, Linnet K, Glenthoj BY, Baandrup L. Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2021 Aug 14;21(1):404. doi: 10.1186/s12888-021-03395-9.

  PMID: 34391393 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Marijuana Abuse

Interventions

Cannabidiol; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lone Baandrup, MD, PhD

  Mental Health Services Capital Region in Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 26, 2019
• Study Start: June 1, 2021
• Primary Completion: November 25, 2025
• Study Completion: March 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication of planned primary and secondary analyses. No end date.
• Access Criteria: Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.

Locations

DK (1)