Status:
RECRUITING
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Baszucki Family Foundation
Conditions:
Bipolar I Disorder
Psychosis
Eligibility:
All Genders
18-45 years
Phase:
NA
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 wi...
Detailed Description
Several lines of evidence show energy metabolism and redox dysregulation in bipolar disorder and psychotic disorders. Ketogenic interventions targeting energy metabolism are promising therapeutic appr...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06221852
Start Date
March 12 2024
End Date
December 30 2027
Last Update
November 5 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478