The efficacy of cannabidiol adjunct to standard treatment in first episode psychosis in young people

Funded Activity Summary

More effective biological treatments in the early course of psychotic disorders are needed, specifically to improve outcomes in people whose psychotic symptoms do not sufficiently improve within the first three months of specialised treatment. This is indicated by a medical records audit from Orygen's early psychosis clinic which found 359 of 535 (67.1%) first episode psychosis (FEP) patients were prescribed a second antipsychotic. Of those on the second antipsychotic, 60.7% (218 of 359) were switched to a third antipsychotic. This shows about two thirds of youth with FEP experience a delay of several months before receiving effective antipsychotic treatment while already being in the service. In this study, we will test cannabidiol (CBD), a non-intoxicating compound of the Cannabis plant for the first time in the early treatment phase of psychotic disorders. Since the therapeutic action of CBD does not appear to depend on dopamine receptor antagonism, this agent may represent a new class of treatment for FEP patients when treatment with conventional antipsychotic medication as sole antipsychotic agent has a low success rate. Specifically, we aim to test whether CBD can improve the relatively low response rate to a second or third trial of antipsychotic medication in 16- to 25-year-olds FEP patients while receiving state-of-the-art care in a specialised early psychosis program. Patients and study design: Randomised controlled trial (RCT) – 200 FEP patients (100 per arm) with insufficient clinical improvement after 6-12 weeks in the service, who consequently are switched to a second or third antipsychotic medication, as per treatment guidelines. Intervention: CBD (per oral) – dose of 1000mg per day (fixed schedule) for 12 weeks. Primary outcome: Change of positive psychotic symptoms on the Positive and Negative Syndrome Scale (PANSS) at 12 weeks. Partners: Orygen; headspace; Lambert Initiative for Cannabinoid Therapeutics, University of Sydney

Funded Activity Details

Start Date: 01-01-2024

End Date: 01-01-2027

Funding Scheme: Funding Scheme not available

Funder: MRFF

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