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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04105231
Other study ID # CBD-P
Secondary ID 2018-004893-84
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2021
Est. completion date June 2025

Study information

Verified date July 2023
Source University of Copenhagen
Contact Lone Baandrup, MD, PhD
Phone 30270879
Email lone.baandrup@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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


Intervention

Drug:
Cannabidiol
Cannabidiol oral suspension
Risperidone
Risperidone, encapsulated tablet.

Locations

Country Name City State
Denmark Center for Neuropsychiatric Schizophrenia Research Glostrup

Sponsors (5)

Lead Sponsor Collaborator
Lone Baandrup Copenhagen University Hospital, Denmark, Danish Center for Sleep Medicine, Glostrup University Hospital, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs) Self-report From baseline to 2 weeks after end of treatment
Other Extrapyramidal and other side effects Udvalget for Kliniske Undersoegelser (UKU) short version A clinician-rated scale to assess antipsychotic side effects 7 weeks follow-up
Primary 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 Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline) Timeline follow back method 7 weeks follow-up
Secondary Cannabis use by self-reported days of cannabis use per week, since last study visit. Timeline follow back method 7 weeks follow-up
Secondary Amount of cannabis use per day, self-reported, since last study visit. PSYSCAN cannabis questionnaire# 6-8 7 weeks follow-up
Secondary Response Response defined by PANSS total 25 percentile changes 7 weeks follow-up
Secondary Remission 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. 7 weeks follow-up
Secondary Global illness severity 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'). 7 weeks follow-up
Secondary Psychosocial functioning Personal and Social Performance Scale (PSP). Higher is better, range 1-100. 7 weeks follow-up
Secondary Neurocognitive functioning Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales. 7 weeks follow-up
Secondary Subjective well-being Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life. 7 weeks follow-up
Secondary Circadian rest-activity cycle Actigraphy. A wrist-worne device that measures kinetic energy. 7 weeks follow-up
Secondary Subjective sleep quality Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales. 7 weeks follow-up
Secondary Objective sleep evaluation Polysomnography (PSG). A measure of objective sleep variables 7 weeks follow-up
Secondary Metabolomics Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood 7 weeks follow-up
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