NCT04105231Active, not recruitingPhase 2
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 22 Sept 2019
- Start date
- 1 Jun 2021
- Primary completion date
- 25 Nov 2025
- Lead sponsor
- Lone Baandrup
- Diseases
- Schizophrenia
- NCT number
- NCT04105231
- EudraCT number
- 2018-004893-84
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 1 Jun 2021 to the primary completion date, 25 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- Severe physical illness that might influence the ability to comply with the protocol
Other
- Treatment resistance as defined by treatment (ever) with clozapine
- Use of self-administered CBD products during the trial
- Patients involuntarily admitted
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Neuropsychiatric Schizophrenia Research Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.