Actively Recruiting
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
Led by University of Pittsburgh · Updated on 2025-12-10
107
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
B
Baszucki Brain Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
CONDITIONS
Official Title
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Not currently following a ketogenic diet
- For Bipolar Disorder hypomanic group: 50% female, 50:50 Bipolar I and Bipolar II diagnosis, Young Mania Rating Scale (YMRS) score above 10, allowed medications include atypical antipsychotics, lithium, antidepressants, anxiolytics
- For Bipolar Disorder euthymic group: 50% female, 50:50 Bipolar I and Bipolar II diagnosis, YMRS score 10 or below, allowed medications include atypical antipsychotics, lithium, antidepressants, anxiolytics
- For Healthy Control group: sex matched with BD groups, no psychiatric history
You will not qualify if you...
- Not between 18 and 40 years of age
- History of head injury, neurological disorder, pervasive developmental disorder, or systemic medical disease
- Mini-Mental State Examination score below 24
- Premorbid National Adult Reading Test IQ estimate below 85
- Visual acuity worse than 20/40 Snellen
- History of alcohol or substance use disorder (except non-abuse cannabis use) within last 6 months
- Current illicit substance use (except cannabis) or intoxication on scan days
- MRI contraindications such as metallic implants, claustrophobia, or pregnancy
- Unable to understand English
- Conditions affecting pancreas, liver, thyroid, or gallbladder
- Taking anticoagulants or having blood coagulation disorders
- Scoring 3 or higher on psychotic symptom questions on PANSS
- Currently following a ketogenic diet
- Head circumference larger than 24 inches (62 cm) or chest circumference larger than 55 inches (139 cm)
- For BD hypomanic group: not meeting sex or diagnosis proportions, diagnosis of BD in manic or euthymic episode, YMRS score 10 or lower, using disallowed psychotropic medications, no smartphone compatible with Keto-Mojo app
- For BD euthymic group: not meeting sex or diagnosis proportions, diagnosis of BD in depressive, hypomanic, or manic episode, YMRS score above 10, using disallowed psychotropic medications, no smartphone compatible with Keto-Mojo app
- For Healthy Control group: not sex-matched with BD groups, psychiatric history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
Jill Morris-Tillman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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