Exploring how diet affects brain function in bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of glucose and ketones on brain metabolism and behavior in individuals with bipolar disorder. Participants will undergo blood tests to assess metabolic function and two MRI scan sessions where they will engage in games that involve potential monetary rewards. The study aims to compare brain responses and energy usage between individuals with bipolar disorder and healthy controls, focusing on how these factors influence risk and reward processing. By understanding these metabolic pathways, the research seeks to shed light on potential dietary interventions for managing bipolar disorder.

Why it matters

Who can join: the full rules

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

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting
• Martinos Center for Biomedical Research, Building 149, 13th Street
  Charlestown, Massachusetts, United States Recruiting
• Laufer Center for Physical and Quantitative Biology , Stony Brook University
  Stony Brook, New York, United States Active not recruiting

Study contacts

• Principal investigator: Lilianne R Mujica-Parodi, Ph.D. — SUNY Stony Brook University
• Study coordinator: Stephen Burke, BS
• Email: stephen.j.burke@stonybrook.edu
• Phone: 914-325-0868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.