RecruitingNot Applicable

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

United States100 participantsStarted 2024-01-26

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stabilization of brain networks (general brain functioning)

Timeframe: Within a month of enrollment completion

Relative stabilization or destabilization of brain networks in response to metabolic bolus

Timeframe: Within a month of enrollment completion

Prefrontal-limbic circuit regulation

Timeframe: Within a month of enrollment completion

Cortico-striatal circuit regulation

Timeframe: Within a month of enrollment completion

Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS)

Timeframe: Within a month of enrollment completion

Trial details

NCT IDNCT06373016

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

Stephen Burke, BS

914-325-0868 stephen.j.burke@stonybrook.edu

View on ClinicalTrials.gov More Bipolar Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Stabilization of brain networks (general brain functioning)

Timeframe: Within a month of enrollment completion

Relative stabilization or destabilization of brain networks in response to metabolic bolus

Timeframe: Within a month of enrollment completion

Prefrontal-limbic circuit regulation

Timeframe: Within a month of enrollment completion

Cortico-striatal circuit regulation

Timeframe: Within a month of enrollment completion

Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS)

Timeframe: Within a month of enrollment completion