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Ketosis for Bipolar Disorder

Charlestown, MA

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

Must not have

History of any lymphoproliferative disorder

Previous treatment with vagus nerve stimulation or deep brain stimulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within a month of enrollment completion

Awards & highlights

No Placebo-Only Group

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

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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

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

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

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes multiply unusually.

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I have had vagus nerve or deep brain stimulation treatment.

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I have had a heart attack or stroke in the past.

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I have trouble swallowing.

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I have been diagnosed with myxedema.

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I have a history of cancer.

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I have a seizure disorder.

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I am a healthy volunteer not on psychotropic medication and have no neurological diseases.

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I regularly take insulin or other diabetes medications.

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I have Type 1 diabetes.

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I do not have any unstable illnesses like heart, liver, kidney, lung, hormone, nerve, or blood disorders.

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I am not pregnant.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS)

Cortico-striatal circuit regulation

Prefrontal-limbic circuit regulation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 14Eligibility criteria met