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RecruitingNot ApplicableNCT06081426

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

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

Sponsor

University of Pittsburgh

Enrollment

107 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria26

  • All participants:
  • -40 years of age
  • Not following a ketogenic diet
  • BD hypomanic group (n=30):
  • 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)
  • Score greater than 10 on the Young Mania Rating Scale score(YMRS)
  • BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  • BD euthymic group (n=30):
  • Meeting sex proportion: 50% female
  • Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)
  • Score less than or equal to 10 on YMRS
  • BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
  • Healthy Control (HC) Group (n=30):
  • Sex matched with BD groups
  • No psychiatric history
  • Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
  • BD euthymic group:
  • 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 greater than 10 on YMRS
  • Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
  • Healthy Control (HC) Group
  • Not sex-matched with BD groups
  • Has psychiatric history

Exclusion Criteria18

  • All participants:
  • Not between 18-40 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
  • 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
  • Unable to understand English
  • Conditions related to the pancreas, liver, thyroid or gallbladder.
  • Taking anticoagulants and/or those with blood dyscrasias (illnesses) who have coagulation disorders (eg, hemophilia) because of the ketomojo finger stick blood tests
  • Scoring 3 or higher on positive symptom factor questions on the Positive and Negative Syndrome Scale (PANSS) questionnaire (indicative of psychotic symptoms)
  • Currently following a ketogenic diet
  • Head circumference larger than 24 inches (62cm) and/or chest circumference larger than 55 inches (139 cm)
  • BD hypomanic group:
  • 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 manic or euthymic episode
  • Score 10 or lower on the Young Mania Rating Scale score(YMRS)

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Interventions

OTHERNon-ketogenic Diet

Consuming a non-ketogenic diet

OTHERKetogenic Diet

Consuming a ketogenic diet

OTHERNo diet

Participants without Bipolar Disorder will not participate in the diet phases of the study

Locations(1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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NCT06081426

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