← Back to Search

Other

Ketone Supplement-MRI/MRS for Bipolar Disorder

N/A

Recruiting

Led By Lilianne R Mujica-Parodi, Ph.D.

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)

Must have vision that is 20/20 or correctable to 20/20 with contact lenses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within a month of enrollment completion

Awards & highlights

Study Summary

"This trial aims to study how different components of diet impact the brain function and behavior of individuals with bipolar disorder. Participants will provide blood samples to assess how the body uses energy, and then undergo two MRI

Who is the study for?

This trial is for individuals with bipolar disorder. Participants will need to provide blood samples and undergo two MRI scan sessions while playing money-winning games, after consuming glucose on one day and ketones on another.Check my eligibility

What is being tested?

The study investigates how diet components like glucose and ketones affect brain function in people with bipolar disorder. It compares the brain's energy use and behavioral responses during risk-reward tasks in an MRI setting.See study design

What are the potential side effects?

Potential side effects are not detailed but may include discomfort from blood draws or reactions to consuming glucose or ketones, as well as possible anxiety or claustrophobia during MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with bipolar disorder according to the DSM-V.

Select...

My vision is 20/20 or can be corrected to 20/20 with contacts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within a month of enrollment completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within a month of enrollment completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within a month of enrollment completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS)

Cortico-striatal circuit regulation

Prefrontal-limbic circuit regulation

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketone Supplement-MRI/MRSExperimental Treatment2 Interventions

Participants (both the Bipolar Cohort and Healthy Comparison Cohort) will be tested twice, both times in an overnight fasting condition (8 hours no food, unrestricted water). Halfway through each of the two scan sessions, participants will be asked to drink either glucose (on one day) or ketones (on the other day). This within-subjects comparison will allow investigators to observe the effects of metabolism on brain function. Participants' glucose and ketone levels will also be measured, using a finger-prick blood measurement at three different times: 1) immediately before the scan session 2) 10 minutes after drinking the glucose or supplement 3) immediately following the scan session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glucose

2017

Completed Phase 4

~850

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor

216 Previous Clinical Trials

39,871 Total Patients Enrolled

1 Trials studying Bipolar Disorder

76 Patients Enrolled for Bipolar Disorder

Massachusetts General HospitalOTHER

2,936 Previous Clinical Trials

13,198,621 Total Patients Enrolled

68 Trials studying Bipolar Disorder

15,424 Patients Enrolled for Bipolar Disorder

Mclean HospitalOTHER

213 Previous Clinical Trials

21,594 Total Patients Enrolled

35 Trials studying Bipolar Disorder

2,182 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Affirmative. Details on clinicaltrials.gov indicate that this study is currently seeking participants. The trial was initially listed on January 26, 2024, and most recently modified on April 15, 2024. A total of 100 individuals are sought across three designated sites for enrollment in the trial."

Answered by AI

Is there a possibility for me to participate in this medical study?

"Individuals diagnosed with bipolar disorder aged between 18 and 45 are eligible for participation in this clinical research, which aims to enroll approximately 100 participants."

Answered by AI

Is the study restricted to individuals younger than 65 years old?

"The eligibility criteria specify that prospective participants must fall within the 18 to 45 age range. It is noteworthy that there are a total of 25 trials catering to individuals under 18 and an additional 126 studies targeting those above 65."

Answered by AI

What is the current number of individuals involved in this research project?

"Yes, information on clinicaltrials.gov confirms that this research is actively seeking participants. This study was first made available on January 26th, 2024, and had its latest update on April 15th, 2024. The trial aims to enroll a total of 100 individuals distributed among three distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Lilianne Strey 2024. "Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373016.

All > Paid Studies Boston > Bipolar Disorder