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Stratification and Treatment in Early Psychosis Study - ENHANCE

Study acronym: STEP-ENHANCE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Sep 2026 to Oct 5, 2026 Show 4 more changesShow less
    • Interventions: CBD 100 mg/mL Oral Solution (Drug), Placebo (Other) to CBD 100 mg/mL Oral Solution (Drug), Placebo (Other)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 14 of 17 entries
    • Site details revised at 2 of 17 sites
  2. Recruitment opened
    • Start date pushed from Aug 2026 to Sep 2026
    • Site details revised at 2 of 17 sites
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2026 to Aug 2026
    • Site details revised at 17 of 17 sites
    v3
  4. Start date: Apr 2025 to Feb 2026
    • Primary completion date: Dec 2027 to Feb 2028
    • Study completion date: Dec 2028 to Feb 2029
    • Collaborators: 25 to 18
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT06778564
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, The Sheba Fund for Health Services and Research, Shalvata Mental Health Center, Geha Mental Health Center, Amsterdam University Medical Center, Hospital General Universitario Gregorio Marañon, National and Kapodistrian University of Athens, Medical University of Vienna, Hospitales Universitarios Virgen del Rocío, University of Campania Luigi Vanvitelli, Psychiatric University Hospital, Zurich
Conditions
(from sponsor)		 Psychosis, First Episode Psychosis, Psychotic Disorders, Psychotic Episode
Related terms Psychotic Disorders
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov