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NCT07434973: STEP-PROMOTE
Stratification and Treatment in Early Psychosis Study - PROMOTE
Phase 3 trial testing Cannabidiol (CBD) in Clinical High Risk for Psychosis (CHR) in 586 participants. Not yet recruiting.
1 December 2029
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 586 |
| Start date | 1 May 2026 |
| Primary completion | 1 December 2029 |
| Estimated completion | 1 December 2031 |
| Sites | 19 locations across Italy, Finland, Netherlands, Greece, Austria, United Kingdom, Germany, Canada |
Drugs / interventions tested
- Cannabidiol (CBD) — full drug profile →
- Placebo
Conditions studied
- Clinical High Risk for Psychosis (CHR) — all drugs for Clinical High Risk for Psychosis (CHR) →
- Clinical High Risk for Psychosis — all drugs for Clinical High Risk for Psychosis →
- Clinical High Risk for Developing Psychosis — all drugs for Clinical High Risk for Developing Psychosis →
Sponsor
University of Oxford
Who can join
Adults 12 to 35, any sex, with Clinical High Risk for Psychosis (CHR) or Clinical High Risk for Psychosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07434973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Clinical High Risk for Psychosis (CHR)
Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07434973 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07434973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing