NCT06373016Recruiting
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Feb 2024
- Start date
- 26 Jan 2024
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Stony Brook University
- Diseases
- Bipolar disorder
- NCT number
- NCT06373016
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 26 Jan 2024 to the primary completion date, 1 Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion/Exclusion Criteria:
- Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)
- Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks
- Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls
- Weight does not exceed 350lbs.
- Diameter does not exceed 60 cm when supine
- HbA1C \< 7%
- No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)
- No claustrophobia
- No history of significant head injury
- No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
- No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation
- Are not deemed a serious suicide or homicide risk
- No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- No seizure disorders
- Have the capacity to sign informed consent
- No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed using urine toxicology test during the initial screening visit and before each MRI scan visit.
- For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease
- Must have vision that is 20/20 or correctable to 20/20 with contact lenses
- No Type 1 diabetes mellitus
- No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.
- No kidney disease, as determined by medical history and/or blood work
- No history of heart attack or stroke
- No difficulty swallowing
- No myxedema
- No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test
- No breastfeeding
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
| Martinos Center for Biomedical Research, Building 149, 13th Street Coordinator of this site? Confirm its status | Charlestown | United States | Recruiting |
| Laufer Center for Physical and Quantitative Biology , Stony Brook University Coordinator of this site? Confirm its status | Stony Brook | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.