Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Launched by LONE BAANDRUP · Sep 24, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of cannabidiol (CBD), a compound found in cannabis, compared to a medication called risperidone for treating psychosis in people who have a history of cannabis use. The trial specifically focuses on individuals aged 18 to 45 who have been diagnosed with certain types of psychotic disorders, like schizophrenia or paranoid psychosis, and who also have experienced symptoms of psychosis. Participants will be assessed based on their mental health symptoms and must have used cannabis at some point in their lives.

If you qualify and decide to participate, you will receive either CBD or risperidone to see how well it helps with your symptoms. The trial is currently recruiting participants, so there is still an opportunity to join. It's important to note that some people, such as those who have been treated with specific medications in the past month or who are pregnant or breastfeeding, may not be eligible to participate. This study aims to find new treatment options for those dealing with these challenging mental health conditions.

Gender

ALL

Eligibility criteria

• 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