Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Description

The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).

Conditions

Bipolar Disorder

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Study Overview

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Study Details

Study overview

The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).

Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Meeting sex proportion: 50% female
  • * Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
  • * Young Mania Rating Scale score(YMRS)\>10
  • * Score \<8 Hamilton Rating Scale for Depression(HRSD)
  • * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  • * Meeting sex proportion: 50% female
  • * Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)
  • * Score \<8 on YMRS
  • * Score \<8 on Hamilton Depression Rating Scale (HRSD)
  • * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  • * Sex matched with BD groups
  • * No psychiatric history
  • * Not between 18-30 years of age
  • * History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
  • * Mini-Mental State Examination score (cognitive state) \<24
  • * Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85
  • * Visual disturbance: \<20/40 Snellen visual acuity
  • * Left/mixed handedness (Annett criteria)
  • * History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (\<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
  • * MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
  • * Unable to understand English
  • * Conditions related to the pancreas, liver, thyroid or gallbladder.
  • * Does not have a smartphone with a) iPhone operating system (iOS) version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
  • * Must be meeting sex proportions: not 50% female
  • * Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5)
  • * Diagnosis of BD in a depressive, manic, or euthymic episode
  • * Young Mania Rating Scale score(YMRS)10 or lower
  • * Score 8 or higher on Hamilton Rating Scale for Depression(HRSD)
  • * Using psychotropic medications other than those allowed in inclusion criteria
  • * Head circumference larger than about 58 cm (size restriction of 7Tesla (7T) scanner)
  • * Not meeting sex proportion: not 50% female
  • * Not meeting diagnosis proportion: not 50:50% BDI:II
  • * Diagnosis of BD in a depressive, hypomanic, or manic episode
  • * Score 8 or higher on YMRS
  • * Score 8 or higher on HRSD
  • * Using psychotropic medications other than those allowed in inclusion criteria
  • * Not sex-matched with BD groups
  • * Has psychiatric history

Ages Eligible for Study

18 Years to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Pittsburgh,

Mary Phillips, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2027-01