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Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Stony Brook University · with Massachusetts General Hospital, Mclean Hospital · NCT06373016

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
2
Study start
January 26, 2024
Record last updated
April 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Glucose; Ketones

Conditions: Bipolar Disorder; Bipolar Disorder Type 1

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • McLean Hospital

    Belmont, MA 02478

    Site contact: Dost Ongur, MD PhD · 617-855-3922 · dongur@mgb.org

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

    Charlestown, MA 02129

    Site contact: Lilianne Mujica-Parodi, PhD · 631-428-8461 · lstrey@mgh.harvard.edu

Study contacts (from the official record)

  • Stephen Burke, BS · 914-325-0868 · stephen.j.burke@stonybrook.edu
  • Sadia Jumana, BS · 339-241-2515 · sadiaanjum.jumana@stonybrook.edu
All mental health studies in Massachusetts →
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder (NCT06373016) | Bored Studies