Stratification and Treatment in Early Psychosis Study -ASSIST
Status:
NOT_YET_RECRUITING
Trial end date:
2029-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this trial is:
* To investigate whether the response to clozapine treatment can be enhanced by adding cannabidiol (CBD), compared to placebo, in treatment resistant psychosis patients.
* To confirm the safety of CBD in people with psychosis.
The trial is a randomised, double-blind, placebo-controlled, multi-centre, international, clinical trial. Individuals with a diagnosis of treatment resistant psychosis in their illness who have had a suboptimal or no response to clozapine treatment will be recruited. These patients are randomised to treatment with oral CBD 500mg twice daily, or a matching placebo for 12 weeks, in addition to clozapine, which is standard care treatment for this population. By using a battery of clinical outcome assessments, the trial will assess several optional biomarkers 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 additional blood samples, stool samples, and complete neuroimaging assessments.
Phase:
PHASE3
Details
Lead Sponsor:
University of Oxford
Collaborators:
Amsterdam University Medical Center Cambridge Cognition Ltd Cambridgeshire and Peterborough NHS Foundation Trust Charite University, Berlin, Germany Douglas Hospital Research Centre Geha Mental Health Center Hospital General Universitario Gregorio Maraon Hospitales Universitarios Virgen del Roco Ludwig Maximilian university of Munich National and Kapodistrian University of Athens Oxford Health NHS Foundation Trust Psychiatric University Hospital, Zurich Shalvata Mental Health Center The Sheba Fund for Health Services and Research University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy University of Campania Luigi Vanvitelli University of Cologne Wellcome Trust West London NHS Trust