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RECRUITING

NCT06373016

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Sponsor: Stony Brook University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-01-26

Completion Date

2027-02-01

Last Updated

2024-04-18

Healthy Volunteers

Yes

Conditions

Bipolar Disorder Bipolar Disorder Type 1

Interventions

DIETARY_SUPPLEMENT

Glucose

A glucose drink is administered midway through one of the scan sessions.

DIETARY_SUPPLEMENT

Ketones

A ketone drink is administered midway through one of the scan sessions.

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

Locations (3)

McLean Hospital

Belmont, Massachusetts, United States

Martinos Center for Biomedical Research, Building 149, 13th Street

Charlestown, Massachusetts, United States

Laufer Center for Physical and Quantitative Biology , Stony Brook University

Stony Brook, New York, United States