Ketogenic diet and nutritional interventions for first episode bipolar disorder
A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT06221852 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Virginie-Anne Chouinard, MD — Mclean Hospital
- Study coordinator: Jacey Anderson, B.A.
- Email: janderson75@mclean.harvard.edu
- Phone: 617-855-3988
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.