Actively Recruiting
Ketogenic Intervention for Bipolar Depression: An Open-Label Trial Guiding Clinical Implementation (KETO-MAYO)
Led by Mayo Clinic · Updated on 2026-01-26
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a ketogenic diet on individuals with bipolar depression, focusing on both mental health and cardiometabolic outcomes. The study aims to understand how therapeutic precision ketosis relates to depressive symptoms and associated metabolic factors in bipolar disorder patients aged 18 to 50 years. This open-label trial is conducted by the Mayo Clinic to guide clinical use of ketogenic interventions in this population. Participants will follow a modified ketogenic diet with structured, intensive guidance and attend weekly behavioral support sessions with a psychiatrist to monitor mood and mental health. The trial lasts six months and assesses changes in depressive symptoms, anxiety, psychosocial function, metabolic markers, inflammation, and mitochondrial function. The study does not include a placebo group and uses an open-label design. Throughout the study, participants will undergo regular assessments at baseline and six months, including mood rating scales, metabolic and inflammatory blood tests, and evaluations of psychosocial wellbeing. Researchers will track adherence to the diet and monitor safety through urine drug screens and pregnancy tests when applicable. The primary outcome is the change in depressive symptoms over six months, with multiple secondary outcomes related to mental health and cardiometabolic health.
CONDITIONS
Brief Title
Ketogenic Intervention for Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-50 years
- Willingness to change current diet to a high fat, low carbohydrate diet
- Diagnosis of bipolar I, bipolar II, or schizoaffective bipolar disorder confirmed by structured clinical interview
- Depressive symptoms of at least mild severity with stable mood for at least 2 weeks
- Negative urine drug screen except for prescribed medications like benzodiazepines
- Negative pregnancy test and established birth control for sexually active participants
- Stable medical conditions such as hypertension, type 2 diabetes, or gout with normal uric acid levels
You will not qualify if you...
- No access to smartphone or internet unless provided by sponsor
- Inability to provide informed consent or pass comprehension assessment
- Diagnosis or symptoms of schizophrenia or psychotic disorders
- Primary diagnosis of personality disorder as determined by psychiatrist
- Mixed depressive symptoms including hypomania
- Active suicidal thoughts or intent
- Current drug or alcohol use disorder except nicotine, or positive toxicology for cannabis use disorder
- Undergoing acute or maintenance brain stimulation treatments except stable vagal nerve stimulation
- Current involuntary psychiatric hospitalization
- Already in ketosis or on medications causing acidosis
- Body mass index below 18.5 or very high LDL cholesterol
- Active or unstable medical conditions posing significant risk
- History of pancreatitis, type I diabetes, or use of SGLT2 inhibitors
- Rare metabolic disorders affecting fat processing
- Significant kidney or liver disease
- Severe vitamin D deficiency
- Osteopenia or history of fragility fractures
- Significant laboratory abnormalities
- Elective surgery planned within 18 weeks
- Family history of premature coronary artery disease
- History of familial hypercholesterolemia or very high LDL or triglycerides
- History of coronary artery disease, stroke, or atherosclerosis
- Respiratory failure or significant respiratory impairment
- Liver failure or chronic liver disease with significant impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants initiate a modified ketogenic diet under structured, intensive guidance and attend weekly behavioral support interviews with a psychiatrist to monitor mental health and mood stability.
Weekly visits for 6 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
K
Karin Lindstrom, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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