RECRUITING

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

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Conditions

Bipolar DisorderKetogenic DietMagnetic Resonance Imaging

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

Official Title

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

Quick Facts

Study Start:2024-01-12
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06081426

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 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meeting sex proportion: 50% female
  2. * Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
  3. * Young Mania Rating Scale score(YMRS)\>10
  4. * Score \<8 Hamilton Rating Scale for Depression(HRSD)
  5. * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  6. * Meeting sex proportion: 50% female
  7. * Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)
  8. * Score \<8 on YMRS
  9. * Score \<8 on Hamilton Depression Rating Scale (HRSD)
  10. * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  11. * Sex matched with BD groups
  12. * No psychiatric history
  1. * Not between 18-30 years of age
  2. * History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
  3. * Mini-Mental State Examination score (cognitive state) \<24
  4. * Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85
  5. * Visual disturbance: \<20/40 Snellen visual acuity
  6. * Left/mixed handedness (Annett criteria)
  7. * 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
  8. * MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
  9. * Unable to understand English
  10. * Conditions related to the pancreas, liver, thyroid or gallbladder.
  11. * 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
  12. * Must be meeting sex proportions: not 50% female
  13. * Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5)
  14. * Diagnosis of BD in a depressive, manic, or euthymic episode
  15. * Young Mania Rating Scale score(YMRS)10 or lower
  16. * Score 8 or higher on Hamilton Rating Scale for Depression(HRSD)
  17. * Using psychotropic medications other than those allowed in inclusion criteria
  18. * Head circumference larger than about 58 cm (size restriction of 7Tesla (7T) scanner)
  19. * Not meeting sex proportion: not 50% female
  20. * Not meeting diagnosis proportion: not 50:50% BDI:II
  21. * Diagnosis of BD in a depressive, hypomanic, or manic episode
  22. * Score 8 or higher on YMRS
  23. * Score 8 or higher on HRSD
  24. * Using psychotropic medications other than those allowed in inclusion criteria
  25. * Not sex-matched with BD groups
  26. * Has psychiatric history

Contacts and Locations

Study Contact

Jill Morris-Tillman
CONTACT
412-383-8206
morristillmanje@upmc.edu

Principal Investigator

Mary Phillips, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Mary Phillips, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2024-01-12
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Ketogenic Diet
  • Magnetic Resonance Imaging

Additional Relevant MeSH Terms

  • Bipolar Disorder