Cannabidiol for treatment of psychosis and cannabis use

Phase 1

• Conditions: on-affective psychosis and comorbid cannabis use; MedDRA version: 20.0Level: LLTClassification code 10037234Term: PsychosisSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10070996Term: Cannabis useSystem Organ Class: 100000004869; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-004893-84-DK
• Lead Sponsor: Mental Health Center Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-27
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

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 non-organic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5)
- Regular use of cannabis at least on a weekly basis during the last 3 months
- Age 18-45 years
- Female participants with reproductive potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, contraceptive injection) or two-barrier methods, i.e. cervical cape and condom
- For female participants a negative pregnancy test is required before inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 oral antipsychotics 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