STEP-ENHANCE
Research type
Research Study
Full title
AUGMENTATION WITH CANNABIDIOL IN FIRST EPISODE PSYCHOSIS: A DOUBLE-BLIND, RANDOMISED CONTROLLED TRIAL
IRAS ID
1008451
Contact name
Belinda Lennox
Contact email
Sponsor organisation
University of Oxford
Research summary
• To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in patients with a first episode of psychosis, who have had a suboptimal or no response to their first antipsychotic treatment.
• To confirm the safety of CBD in people with psychosis.The study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These patients are randomised to treatment with oral CBD 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used to predict clinical outcomes and response to treatment with CBD. Biomarkers are being assessed as an exploratory outcome measure. Participants will be invited to provide blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.
REC name
Wales REC 2
REC reference
24/WA/0269
Date of REC Opinion
23 Oct 2024
REC opinion
Further Information Favourable Opinion