Adding ketones to antipsychotics in young adults with first episode psychosis
Official title: Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis
Run by Université de Sherbrooke · NCT07122531 · Data updated 2026-11-12
This study tests whether giving exogenous ketones on top of antipsychotic treatment helps young adults experiencing a first episode of psychosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 35 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Status | Recruiting |
| Started | August 26, 2025 |
| Main results expected | April 15, 2027 |
| Study ends | August 15, 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07122531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a first episode of psychosis who are on a stable dose of a second- or third-generation antipsychotic and can consent in French or English.
✕Probably not a fit
Individuals with diabetes, recent ketogenic interventions, or certain metabolic disorders may not benefit and may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial investigates the clinical and metabolic effects of adding medium-chain triglyceride (MCT) oil-derived ketones to ongoing antipsychotic therapy in adults with first episode psychosis. Participants are adults receiving a stable dose of second- or third-generation antipsychotics and able to consent, funded by Université de Sherbrooke and conducted at Hotel-Dieu CIUSSS de l'Estrie-CHUS in Sherbrooke. The intervention uses MCT oil to provide exogenous ketones, with outcomes focused on psychiatric symptoms and metabolic health. The study builds on existing knowledge that brain energy metabolism may be altered in early psychosis and that antipsychotics carry metabolic risks. Eligibility requires language ability in French or English and exclusion criteria cover pregnancy, diabetes, recent ketogenic interventions, and certain metabolic disorders.
Why it matters
Potential benefit: If successful, adding ketones could improve psychiatric symptoms and metabolic health in first episode psychosis patients receiving antipsychotics.
How similar studies have gone: Previous research has begun to explore metabolic adjuncts in psychosis, but this exact ketone supplementation approach in FEP is novel or limited in published success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Referred or self-referred to the PEP Clinic of the Estrie region, either as an outpatient or inpatient. * Currently receiving a second- or third-generation antipsychotic at a stable dose for at least 4 weeks. * Able to read and communicate in French or English. * Capable of understanding and signing the informed consent form. Exclusion Criteria: * Pregnancy, childbirth within the past 6 months, or breastfeeding. * any use of MCT oil, ketone salts, or a ketogenic diet within the past year. * Previous diagnosis of type I or type II diabetes. * Uncontrolled acute suicidal ideation at the time of inclusion in the PEP clinic. * Other conditions that may interfere with participation, as determined by the qualified physician. * Pancreatitis (inflammation of the pancreas) or liver failure. * Metabolic condition affecting fat metabolism or inherited carnitine deficiency and its related enzymes. * Porphyria. * Pyruvate kinase deficiency. * Neurodevelopmental disorder of unknown etiology or rare genetic disease.
Where it's running
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Hotel-Dieu CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Kevin Zemmour, MD — Université de Sherbrooke
- Study coordinator: Melanie Fortier, M.Sc
- Email: melanie.fortier2@usherbrooke.ca
- Phone: 1-819-821-5206
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.