Stratification and Treatment in Early Psychosis Study - ENHANCE

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.

Conditions

• Psychosis
• First Episode Psychosis
• Psychotic Disorders
• Psychotic Episode

Interventions

DRUG

CBD 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

OTHER

Placebo

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

Sponsors & Collaborators

• Wellcome Trust

  collaborator OTHER

• Cambridge Cognition Ltd

  collaborator INDUSTRY

• Cambridgeshire and Peterborough NHS Foundation Trust

  collaborator OTHER

• Oxford Health NHS Foundation Trust

  collaborator OTHER_GOV

• West London NHS Trust

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• Ludwig Maximilian university of Munich

  collaborator UNKNOWN

• The Sheba Fund for Health Services and Research

  collaborator UNKNOWN

• Shalvata Mental Health Center

  collaborator OTHER

• Geha Mental Health Center

  collaborator OTHER

• Amsterdam University Medical Center

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• Psychiatric University Hospital, Zurich

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Philip McGuire, PhD MD · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2028-02-29

Completion

2029-02-28

Countries

• Austria
• Germany
• Greece
• Israel
• Italy
• Netherlands
• Spain
• Switzerland
• United Kingdom

Study Locations