NCT06081426 Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
| NCT ID | NCT06081426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 107 participants in total. It began in 2024-01-12 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 Criteria: 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 * 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. * 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) * Using psychotropic medications other than those allowed in inclusion criteria * 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 * Using psychotropic medications other than those allowed in inclusion criteria * 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
Contact & Investigator
Mary Phillips, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06081426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06081426 currently recruiting?
Yes, NCT06081426 is actively recruiting participants. Contact the research team at morristillmanje@upmc.edu for enrollment information.
Where is the NCT06081426 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06081426 clinical trial?
NCT06081426 is sponsored by University of Pittsburgh. The principal investigator is Mary Phillips, MD at University of Pittsburgh. The trial plans to enroll 107 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.