Effects of a ketone drink on schizophrenia and bipolar disorder symptoms
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
This study is testing if a ketone drink can help improve symptoms and thinking skills in people with schizophrenia and bipolar disorder compared to a regular carbohydrate drink.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT06426134 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether a ketone drink can improve signs and symptoms in patients with schizophrenia-spectrum disorders and bipolar-spectrum disorders. Participants will consume both a ketone drink and an isocaloric carbohydrate drink in a randomized order, with assessments including EEG/EMG for information processing, cognitive tests, and mood evaluations. The study aims to explore improvements in cognitive functioning, metabolism, inflammation, and circadian rhythm. The crossover design allows for direct comparison of the effects of the two drinks within the same individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older experiencing a first episode of psychosis or a (hypo)manic or depressive episode related to schizophrenia or bipolar disorder.
Not a fit: Patients with substance-induced psychosis, metabolic diseases, or significant comorbidities such as diabetes, liver, kidney, or cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to enhance cognitive and emotional functioning in patients with schizophrenia and bipolar disorder.
How similar studies have performed: While the use of ketone drinks in psychiatric conditions is relatively novel, preliminary studies suggest potential benefits, though this specific approach remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder) * Age \>= 18 years old * Receiving standard care (including antipsychotic and mood stabilizing medication) * Mentally competent to give informed consent: Exclusion Criteria: * Substance use as cause of psychosis or (hypo)mania * Substance use (other than nicotine) in the week prior to study onset * Intellectual disability * Diabetes mellitus (type 1 or type 2) * Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood) * Liver disease * Kidney disease * Cardiovascular disease * Pregnancy * Breastfeeding
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam UMC, dept. Psychiatry — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Karin Huizer, MD/PhD — Parnassia Groep
- Study coordinator: Karin Huizer, MD/PhD
- Email: k.huizer@parnassiagroep.nl
- Phone: +31683048776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.