Stratification and Treatment in Early Psychosis Study - PROMOTE (NCT07434973)
ImPRoving OutcoMes in Individuals at Clinical High Risk fOr Psychosis Using Cannabidiol: a Double-blind, Randomised conTrollEd Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: MedUni Vienna, Department of Child and Adolescent Psychiatry — Vienna
Age range: 12 Years to 35 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- MedUni Vienna, Department of Child and Adolescent Psychiatry — Vienna,
- Douglas Hospital Research Centre — Montreal,
- University Hospital Turku — Turku,
- Vivantes Network for Health GmbH — Berlin,
- University of Cologne, Faculty of Medicine and University Hospital of Cologne — Cologne,
- University Medical Center Schleswig-Holstein — Lübeck,
- Ludwig Maximilian University Hospital — München,
- National and Kapodistrian University of Athens — Athens,
- University of Bari Aldo Moro — Bari,
- University of Campania L. Vanvitelli — Naples,
- University of Pavia — Pavia,
- IRCCS Santa Lucia Foundation — Roma,
- Stichting Amsterdam UMC — Amsterdam,
- Biobizkaia Health Research Institute (Asociación Instituto de Investigación Sanitaria) — Bilbao,
- Foundation for Biomedical Research of the Gregorio Marañón Hospital (FIBHGM) — Madrid,
- Psychiatric University Hospital (PUK) — Zurich,
- Cambridgeshire and Peterborough NHS Foundation Trust — Cambridge,
- Institute of Psychiatry, Psychology & Neuroscience, King's College London — London,
- Oxford Health NHS Foundation Trust (OHFT) — Oxford,
📞 Contact the Study Coordinator
Phone: +44 7900206137
Email: steptrials@phc.ox.ac.uk
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clinical High Risk for Psychosis (CHR)
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- Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis — Los Angeles, California
- A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis — Irvine, California
- Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis — New York, New York
- Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis — Verdun, Quebec
Explore by condition: All Clinical High Risk for Psychosis (CHR) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.