RECRUITING

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Quick Facts

Study Start:2024-01-26
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06373016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)
  2. * Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks
  3. * Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls
  4. * Weight does not exceed 350lbs.
  5. * Diameter does not exceed 60 cm when supine
  6. * HbA1C \< 7%
  7. * No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)
  8. * No claustrophobia
  9. * No history of significant head injury
  10. * No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
  11. * No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation
  12. * Are not deemed a serious suicide or homicide risk
  13. * No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
  14. * No seizure disorders
  15. * Have the capacity to sign informed consent
  16. * 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.
  17. * For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease
  18. * Must have vision that is 20/20 or correctable to 20/20 with contact lenses
  19. * No Type 1 diabetes mellitus
  20. * No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.
  21. * No kidney disease, as determined by medical history and/or blood work
  22. * No history of heart attack or stroke
  23. * No difficulty swallowing
  24. * No myxedema
  25. * No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test
  26. * No breastfeeding

Contacts and Locations

Study Contact

Annabel Driussi, MA
CONTACT
510-333-6732
annabel.driussi@stonybrook.edu
Janaki Raghavan, PhD
CONTACT
774-479-2660
janaki.raghavan@stonybrook.edu

Principal Investigator

Lilianne R Mujica-Parodi, Ph.D.
PRINCIPAL_INVESTIGATOR
SUNY Stony Brook University

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States
Martinos Center for Biomedical Research, Building 149, 13th Street
Charlestown, Massachusetts, 02129
United States
Laufer Center for Physical and Quantitative Biology , Stony Brook University
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Stony Brook University

  • Lilianne R Mujica-Parodi, Ph.D., PRINCIPAL_INVESTIGATOR, SUNY Stony Brook University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-26
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2024-01-26
Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder
  • Bipolar Disorder Type 1