Tests a ketogenic diet alongside usual care for first-episode bipolar disorder
Tests a ketogenic diet with usual care in adults with first-episode bipolar disorder.
Plain-language title generated from the registry record
Registry title: Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Key facts
- Where
- Belmont, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06221852, who can take part
Where in United States
- McLean HospitalBelmont, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mclean Hospital
- Trial code
- NCT06221852
- Record updated
- 17 August 2026
- Original description
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.Read full original descriptionShow less
A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Inclusion: 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: Concomitant treatment with Propofol; Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease); Current DSM-5 substance use disorder; 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; Unable to sign informed consent; Contraindication to magnetic resonance (MR) scan (including claustrophobia); 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); Familial hypercholesterolemia.