What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers like lithium, antipsychotics, and anticonvulsants. Lithium can cause side effects such as tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Antipsychotics may lead to weight gain, metabolic syndrome, and extrapyramidal symptoms. Anticonvulsants can cause dizziness, weight gain, and gastrointestinal issues. These treatments aim to stabilize mood and alter brain metabolism, similar to the ketogenic diet, but they come with their own set of potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for Bipolar Disorder primarily include mood stabilizers such as lithium, anticonvulsants like valproate and lamotrigine, and atypical antipsychotics such as quetiapine and olanzapine. These treatments generally work by stabilizing mood and altering neurotransmitter activity rather than directly shifting metabolic pathways as the ketogenic diet does. However, lithium has been noted to affect brain metabolism, including lactate levels, which may have some parallels to the metabolic shifts seen with a ketogenic diet. While no FDA-approved treatments specifically mimic the ketogenic diet's mechanism of shifting energy sources to ketone bodies, ongoing research is exploring the potential benefits of such metabolic interventions in managing Bipolar Disorder.

What other types of research exist?

Promising novel alternatives to the Ketogenic Diet for Bipolar Disorder patients include: 1) Choline augmentation with lithium, which has shown substantial reduction in manic and mood symptoms. 2) Omega-3 fatty acids combined with lithium and aripiprazole, which can reduce oxidative stress and prevent mania. 3) Ketamine, particularly intranasal administration, which has shown significant improvement in treatment-resistant cases.

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Ketogenic Diet for Bipolar Disorder

Q: What is the mechanism of action of this treatment?

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.

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 is testing if a high-fat, low-carb diet can help adults with Bipolar Disorder. The diet increases a substance that might reduce severe mood swings. Researchers will use various methods to study its effects on brain activity and emotions. The diet may have mood-stabilizing properties.

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.

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.

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

Select...

I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not sex-matched with BD groups and have a psychiatric history.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (all participants)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

0 / 3Eligibility criteria met

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

1,762 Previous Clinical Trials

16,347,896 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

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