Actively Recruiting
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Led by Stony Brook University · Updated on 2026-04-15
100
Participants Needed
3
Research Sites
157 weeks
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior.
CONDITIONS
Official Title
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of bipolar disorder confirmed by Structured Clinical Interview for DSM
- Stable and euthymic mood at time of consent and testing with no hospitalizations in past 4 weeks
- Age between 18 and 45 years
- Weight less than or equal to 350 lbs
- Body diameter less than or equal to 60 cm when lying down
- HbA1C less than 7%
- Vision 20/20 or correctable to 20/20 with contact lenses
- Capacity to sign informed consent
- For healthy volunteers: no psychotropic medication use or history of neurological disease
You will not qualify if you...
- Presence of non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)
- Claustrophobia
- History of significant head injury
- Electroconvulsive therapy or transcranial magnetic stimulation within last 3 months
- Previous vagus nerve stimulation or deep brain stimulation treatments
- Serious suicide or homicide risk
- Unstable medical illnesses including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological diseases
- Seizure disorders
- Current or recent (within 6 months) alcohol or substance use disorder or positive illicit drug test (except cannabis)
- Type 1 diabetes mellitus
- Regular use of insulin or other antidiabetics such as Metformin, GLP1-RA's
- Kidney disease
- History of heart attack or stroke
- Difficulty swallowing
- Myxedema
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
2
Martinos Center for Biomedical Research, Building 149, 13th Street
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
3
Laufer Center for Physical and Quantitative Biology , Stony Brook University
Stony Brook, New York, United States, 11794
Active, Not Recruiting
Research Team
S
Stephen Burke, BS
CONTACT
S
Sadia Jumana, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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