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Stratification and Treatment in Early Psychosis Study - PROMOTE

NCT07434973 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2026-02-27

No results posted yet for this study

Summary

The purpose of this trial is:

* To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.
* To confirm the safety of CBD in individuals at clinical high risk for psychosis.

The trial is a randomised, double-blind, placebo-controlled, multi-centre, international clinical trial. Individuals meeting clinical high risk for psychosis criteria will be recruited for the trial intervention component of the trial. Participants are randomised to treatment with oral CBD 300mg (oral solution 100 mg/mL) twice daily, or a matching placebo, for 104 weeks. By using a battery of clinical outcome assessments, the trial will be able to assess several biomarkers to predict clinical outcomes and response to treatment with CBD. Participants will be invited to provide blood samples, stool samples, cerebrospinal fluid samples (if aged 18 years or over) and complete neuroimaging assessments. Individuals who are not found to have mental illness as defined by DSM-5 criteria will be recruited to a healthy control group, to validate the biomarker component of the trial.

Additionally, a control group of healthy volunteers will be recruited who will not take the trial intervention to aid calibration between datasets from sites acquiring MRI data and to inform and validate any possible multivariate signature associated with the CHR-P state, course or outcome by understanding how these measures are different in controls. Healthy controls will also be used for secondary case-control comparisons. Healthy controls will undergo clinical and biomarker assessments only.

Conditions

  • Clinical High Risk for Psychosis (CHR)
  • Clinical High Risk for Psychosis
  • Clinical High Risk for Developing Psychosis

Interventions

DRUG

Cannabidiol (CBD)

CBD 100 mg/mL Oral Solution

DRUG

Placebo

Placebo for Cannabidiol oral solution 100mg/mL oral solution

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Philip McGuire, PhD, MD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-12-01
Completion
2031-12-01

Countries

  • Austria
  • Canada
  • Finland
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434973 on ClinicalTrials.gov