NCT06373016 Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
| NCT ID | NCT06373016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stony Brook University |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-01-26 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Lilianne R Mujica-Parodi, Ph.D.
PRINCIPAL INVESTIGATOR
SUNY Stony Brook University
Frequently Asked Questions
Who can join the NCT06373016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06373016 currently recruiting?
Yes, NCT06373016 is actively recruiting participants. Contact the research team at stephen.j.burke@stonybrook.edu for enrollment information.
Where is the NCT06373016 trial being conducted?
This trial is being conducted at Belmont, United States, Charlestown, United States, Stony Brook, United States.
Who is sponsoring the NCT06373016 clinical trial?
NCT06373016 is sponsored by Stony Brook University. The principal investigator is Lilianne R Mujica-Parodi, Ph.D. at SUNY Stony Brook University. The trial plans to enroll 100 participants.
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