💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
McLean Hospital
Belmont, United States
Martinos Center for Biomedical Research, Building 149, 13th Street
Charlestown, United States
Laufer Center for Physical and Quantitative Biology , Stony Brook University
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky