Studies how a ketogenic diet may affect brain activity in bipolar disorder
Tests a ketogenic diet's effect on brain activity and mood in adults with bipolar disorder.
Plain-language title generated from the registry record
Registry title: Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
Key facts
- Where
- Pittsburgh, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT06081426, who can take part
Where in United States
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Pittsburgh
- Trial code
- NCT06081426
- Record updated
- 10 December 2025
- Original description
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).Read full original descriptionShow less
Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Inclusion: All participants:; 18-40 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.
Exclusion: MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy; Using psychotropic medications other than those allowed in inclusion criteria; Using psychotropic medications other than those allowed in inclusion criteria; History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report); 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; 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); Has psychiatric history; Not between 18-40 years of age; All participants:; 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; Unable to understand English; 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); 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.