Ketogenic diet and nutritional interventions for first episode bipolar disorder
Official title: A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
Run by Mclean Hospital · NCT06221852 · Data updated 2026-11-12
This study is testing if a ketogenic diet, along with regular treatment, can help people who are having their first episode of bipolar disorder or schizoaffective disorder feel better and improve their brain health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | September 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06221852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 45 with a recent diagnosis of bipolar I disorder or schizoaffective disorder who can adhere to dietary interventions.
✕Probably not a fit
Patients with unstable medical conditions, substance use disorders, or those unable to participate in MRI scans may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of a ketogenic diet combined with standard treatment on brain energy metabolism and psychiatric symptoms in individuals experiencing their first episode of bipolar disorder or schizoaffective disorder. The study employs a randomized controlled design over 12 weeks, utilizing multimodal imaging and metabolic measures to assess the impact of nutritional ketosis on mood and psychotic symptoms. Participants will be monitored for changes in energy metabolism and other neurometabolic markers, with the goal of improving recovery outcomes for early-stage patients.
Why it matters
Potential benefit: If successful, this intervention could provide a novel dietary approach to improve mood and reduce psychotic symptoms in patients with first episode bipolar disorder.
How similar studies have gone: While ketogenic diets have shown promise in other psychiatric conditions, this specific approach for first episode bipolar disorder is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 18 and 45. * Ability to adhere to study diets. * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years. * Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening * Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study. Exclusion Criteria: * Unable to sign informed consent * Contraindication to magnetic resonance (MR) scan (including claustrophobia) * Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease) * Current DSM-5 substance use disorder * Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception * Have a body weight of over 350 lbs or a body mass index (BMI) \<20 * Score above 15 on the Young Mania Rating Scale (YMRS) * History of significant head injury * Current cancer diagnosis * Current diagnosis of type 1 or type 2 Diabetes Mellitus * History of gastric bypass surgery or any weight loss surgery * Concomitant treatment with Propofol * Familial hypercholesterolemia
Where it's running
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McLean Hospital
Belmont, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Virginie-Anne Chouinard, MD — Mclean Hospital
- Study coordinator: Kaitlin Shannon, B.A.
- Email: kshannon6@mgb.org
- Phone: 617-855-2410
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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.