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Ketogenic Diet for Bipolar Disorder

N/A
Recruiting
Led By Mary Phillips, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants: 18-30 years of age
Be between 18 and 65 years old
Must not have
All participants: Not between 18-30 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, Left/mixed handedness (Annett criteria), 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., 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
Healthy Control (HC) Group: Not sex-matched with BD groups, Has psychiatric history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scan 3 at end of second dietary phase (8-10 weeks) (participants with bipolar disorder)
Awards & highlights

Summary

This trial looks at how a keto diet affects brain, metabolism, and emotions in adults with Bipolar Disorder.

Who is the study for?
Adults aged 18-30 with Bipolar Disorder, either hypomanic or euthymic, who are taking certain BD medications can join. Healthy controls without psychiatric history are also needed. Exclusions include head injury, systemic diseases, substance abuse (except limited cannabis), poor English understanding, and specific medical conditions.Check my eligibility
What is being tested?
The trial is testing the effects of a ketogenic diet versus no diet change or a non-ketogenic diet on brain function and mood in people with Bipolar Disorder. Participants will be monitored to see how their brain activity and emotional state respond to dietary changes.See study design
What are the potential side effects?
Potential side effects from the ketogenic diet may include digestive discomfort, changes in energy levels, nutrient deficiencies if not properly managed, and possible exacerbation of existing health issues related to pancreas, liver, thyroid or gallbladder.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not sex-matched with BD groups and have a psychiatric history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (all participants)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (all participants) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood oxygen level-dependent (BOLD) signal at Scan 1
Blood oxygen level-dependent (BOLD) signal at Scan 2
Blood oxygen level-dependent (BOLD) signal at Scan 3
+42 more
Secondary outcome measures
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Average total sleep time during Ketogenic vs Normal diet
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: No dietExperimental Treatment1 Intervention
Participants without Bipolar Disorder will not participate in the diet phases of the study
Group II: 1st phase Non-ketogenic Diet / 2nd phase Ketogenic DietExperimental Treatment2 Interventions
Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study
Group III: 1st phase Ketogenic Diet / 2nd phase Non-ketogenic DietExperimental Treatment2 Interventions
Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Bipolar Disorder include lithium, ketamine, and the ketogenic diet. Lithium stabilizes mood by modulating neurotransmitter activity and intracellular signaling pathways, particularly the PI3K-AKT pathway. Ketamine, an NMDA receptor antagonist, provides rapid antidepressant effects by enhancing synaptic plasticity and increasing glutamate transmission. The ketogenic diet alters brain activity and metabolism by shifting the energy source from carbohydrates to fats, leading to the production of ketone bodies, which may stabilize mood by providing a more efficient energy source for brain cells. Understanding these mechanisms is crucial for Bipolar Disorder patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.
Chronic lithium treatment ameliorates ketamine-induced mania-like behavior via the PI3K-AKT signaling pathway.Metabolomic signatures of drug response phenotypes for ketamine and esketamine in subjects with refractory major depressive disorder: new mechanistic insights for rapid acting antidepressants.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,339,150 Total Patients Enrolled
27 Trials studying Bipolar Disorder
5,642 Patients Enrolled for Bipolar Disorder
Baszucki Brain Research FundOTHER
6 Previous Clinical Trials
208 Total Patients Enrolled
5 Trials studying Bipolar Disorder
198 Patients Enrolled for Bipolar Disorder
Mary Phillips, MDPrincipal InvestigatorUniversity of Pittsburgh
~71 spots leftby Jan 2027