RecruitingPhase 3NCT06778564

Stratification and Treatment in Early Psychosis Study - ENHANCE

Augmentation With Cannabidiol in First Episode Psychosis: a Double-blind, Randomised Controlled Trial


Sponsor

University of Oxford

Enrollment

250 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is: * To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants 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 participants are randomised to treatment with CBD oral solution 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.


Eligibility

Min Age: 16 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CBD 100 mg/mL Oral Solution and Placebo for people with first-episode psychosis, psychosis, and other related conditions. The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCBD 100 mg/mL Oral Solution

Daily dose 1000mg, taken as 500mg (5ml) b.i.d for 6 weeks. For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks

OTHERPlacebo

5ml b.i.d for 6 weeks; For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks


Locations(17)

MedUni Vienna

Vienna, Austria

University of Augsburg

Augsburg, Germany

Charité Universitätsmedizin

Berlin, Germany

University Hospital Cologne

Cologne, Germany

Ludwig-Maximilian-University Munich

Munich, Germany

National and Kapodistrian University of Athens

Athens, Greece

Shalvata Mental Health Center

Hod HaSharon, Israel

Geha Mental Health Center

Petah Tikva, Israel

Sheba Medical Centre

Ramat Gan, Israel

University of Campania 'Luigi Vanvitelli'

Naples, Italy

Stichting Amsterdam UMC

Amsterdam, Netherlands

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Psychiatric University Hospital (PUK), Zurich

Zurich, Switzerland

Cambridgeshire and Peterborough NHS Foundation Trust

Cambridge, United Kingdom

West London NHS Trust

London, United Kingdom

Oxford Health NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06778564


Related Trials