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Stratification and Treatment in Early Psychosis Study -ASSIST

Study acronym: STEP-ASSIST
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Start date: Jun 2026 to Jan 2027 Show 4 more changesShow less
    • Interventions: CBD 100 mg/mL Oral Solution (Drug), Placeb (Drug) to CBD 100 mg/mL Oral Solution (Drug), Placeb (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 16 of 17 entries
    • Site details revised at 3 of 15 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07326124
Lead Sponsor University of Oxford
Collaborators: Wellcome Trust, Cambridge Cognition Ltd, Cambridgeshire and Peterborough NHS Foundation Trust, Oxford Health NHS Foundation Trust, West London NHS Trust, Charite University, Berlin, Germany, University of Cologne, Ludwig-Maximilians - University of Munich, University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, The Sheba Fund for Health Services and Research, Shalvata Mental Health Center, Geha Mental Health Center, Amsterdam University Medical Center, National and Kapodistrian University of Athens, Hospital General Universitario Gregorio Marañon, Hospitales Universitarios Virgen del Rocío, University of Campania Luigi Vanvitelli, Psychiatric University Hospital, Zurich, Douglas Hospital Research Centre
Conditions
(from sponsor)		 Treatment Resistant Psychosis, Psychosis
Related terms Psychotic Disorders
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov