Actively Recruiting
Ketogenic Intervention for Bipolar Depression
Led by Mayo Clinic · Updated on 2026-01-26
30
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketogenic Intervention for Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-50 years
- Willingness to change to a high fat, low carbohydrate diet
- Diagnosis of bipolar I, bipolar II, or bipolar schizoaffective disorder confirmed by structured interview
- Mild or greater depressive symptoms with stable mood for at least 2 weeks on mood stabilizers or non-psychotropic medication
- Negative urine drug screen except for prescribed medications like benzodiazepines
- Negative pregnancy test
- Use of established birth control if sexually active
- Stable medical conditions like hypertension, type 2 diabetes, or normal uric acid levels
You will not qualify if you...
- No access to smartphone or internet unless provided
- Unable to provide voluntary informed consent or fail comprehension assessment
- Diagnosis of schizophrenia or presence of psychotic symptoms
- Primary diagnosis of personality disorder
- Mixed depressive and hypomanic symptoms
- Active suicidal ideation or intent
- Current drug or alcohol use disorder except nicotine; remission less than 3 months
- Positive toxicology for cannabis or cannabis use disorder with high CUDIT-R score
- Currently receiving ECT, transcranial magnetic stimulation, or deep brain stimulation treatments (except maintenance vagal nerve stimulation over 1 year old)
- Current involuntary psychiatric hospitalization
- Already in ketosis or taking medications causing acidosis
- BMI under 18.5 or high baseline LDL cholesterol
- Active or unstable medical conditions posing significant risk
- History of acute or lipid-associated pancreatitis
- Type I diabetes
- Use of SGLT2 inhibitors
- Rare metabolic disorders affecting fat processing
- Chronic kidney failure or severe renal disease
- Severe vitamin D deficiency
- Diagnosis of osteopenia or history of fragility fractures
- Significant lab test abnormalities
- Planned elective surgery within 18 weeks
- Family history of early coronary artery disease
- History of familial hypercholesterolemia or very high LDL or triglycerides
- History of coronary disease, stroke, carotid plaque, or peripheral arterial disease
- Respiratory failure or significant respiratory impairment
- Liver failure or chronic liver disease with severe impairment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
K
Karin Lindstrom, PhD
CONTACT
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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