RecruitingNot ApplicableNCT07121894

Ketogenic Intervention for Bipolar Depression

Ketogenic Intervention for Bipolar Depression: An Open-Label Trial Guiding Clinical Implementation (KETO-MAYO)


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the clinical correlates of therapeutic precision ketosis in bipolar depression and to evaluate the cardiometabolic correlates associated with therapeutic precision ketosis in bipolar depression.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic (high-fat, very low-carbohydrate) diet can help reduce depression in people with bipolar disorder who are already on mood-stabilizing medication. **You may be eligible if...** - You are 18–50 years old - You have a diagnosis of bipolar I, bipolar II, or bipolar schizoaffective disorder - You are currently experiencing at least mild depression - You have been on stable mood-stabilizing medication for at least 2 weeks - You are willing to switch to a ketogenic diet - You are not pregnant and using birth control if sexually active **You may NOT be eligible if...** - You have Type 1 diabetes, kidney failure, pancreatitis, or are on dialysis - You have active suicidal thoughts or plans - You have a current drug or alcohol use disorder - You have a history of heart disease, stroke, or significant cardiovascular problems - You have severe liver disease or significant osteopenia/osteoporosis - You are already in a ketogenic state or on medications that cause acidosis (e.g., topiramate) - You have a rare fat metabolism disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALKetogenic Diet

Participants will initiate a modified ketogenic diet under structured, intensive guidance. Simultaneously, participants will attend weekly behavioral support interviews with a psychiatrist to monitor mental health and mood stability.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07121894


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