NCT06221852 Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
| NCT ID | NCT06221852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mclean Hospital |
| Condition | Bipolar I Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-03-12 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Virginie-Anne Chouinard, MD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT06221852 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Bipolar I Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06221852 currently recruiting?
Yes, NCT06221852 is actively recruiting participants. Contact the research team at janderson75@mclean.harvard.edu for enrollment information.
Where is the NCT06221852 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT06221852 clinical trial?
NCT06221852 is sponsored by Mclean Hospital. The principal investigator is Virginie-Anne Chouinard, MD at Mclean Hospital. The trial plans to enroll 50 participants.
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