Actively Recruiting
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Led by Mclean Hospital · Updated on 2025-11-05
50
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
B
Baszucki Family Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 45.
- Able to follow the study diets.
- Diagnosed with bipolar I disorder or schizoaffective disorder within the last 7 years according to DSM-5.
- Stable psychiatric condition with no medication changes in the past 2 weeks.
- Not expected to need new psychiatric medications during the 12-week study.
You will not qualify if you...
- Unable to provide informed consent.
- Contraindications to MRI scanning, including claustrophobia.
- Unstable medical illnesses such as cardiovascular, liver, kidney, lung, endocrine, neurological, or blood diseases.
- Current substance use disorder as defined by DSM-5.
- Pregnant, nursing, or of childbearing potential without medically accepted contraception.
- Body weight over 350 pounds or BMI under 20.
- Young Mania Rating Scale score above 15.
- History of significant head injury.
- Current cancer diagnosis.
- Diagnosis of type 1 or type 2 diabetes mellitus.
- History of gastric bypass or other weight loss surgery.
- Use of Propofol treatment.
- Familial hypercholesterolemia.
AI-Screening
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Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
J
Jacey Anderson, B.A.
CONTACT
V
Virginie-Anne Chouinard, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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