Who is eligible for clinical trial NCT07121894?

Participants must meet the protocol's inclusion criteria for Bipolar Depression. The stated age range is 18 Years to 50 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07121894 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-14

Ketogenic Intervention for Bipolar Depression (NCT07121894)

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

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (31 items).

Location: Mayo Clinic in Rochester — Rochester, Minnesota

Age range: 18 Years to 50 Years

🧪 Interventions in This Study

Ketogenic Diet (BEHAVIORAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age 18-50 years
Willingness to change the current diet to a high fat, low carbohydrate diet
Diagnosis of bipolar I or II disorder, or BP schizoaffective Disorder by DSM-IV (SCID- confirmed). If a participant has already completed a structured diagnostic interview within the last 2 years or in any of the Department of Psychiatry and Psychology Mood Unit studies, existing SCID results can be used for this study; thus, they will not be required to repeat the SCID assessment. If a structured diagnostic interview was completed more than 2 years ago, the current mood state sections of the SCID must be repeated to ensure accuracy of current mood state assessment.
Depressive symptom severity of at least mild (MADRS \> 6) with steady and stable (ie, at least 2 weeks) mood stabilization (eg, lithium, valproate, lamotrigine, carbamazepine/oxcarbamazepine, and/or atypical antipsychotic therapy) and non-psychotropic medication.
Urine drug screen is negative except for allowable drugs that they have been prescribed, such as benzodiazepines.
Pregnancy test is negative.
Established birth control practice for sexually active individuals.
Medical comorbidity is stable (hypertension, T2D, gout - uric acid in normal limits).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
No access to smartphone or internet (unless provided by sponsor)
Inability to provide written, voluntary, informed consent and pass (80%) comprehension assessment related to study goals, risks, and benefits.
Structured clinical interview confirmation of schizophrenia or presence of psychotic symptoms (both SCID and YMRS question 8\>5).
Clinical diagnosis of personality disorder that, upon review by the study psychiatrist, of all available information (SCID, electronic health record), is the primary psychiatric diagnosis.
Mixed symptoms of depression defined as a YMRS ≥12 (i.e., hypomania).
Active suicidal ideation as defined by MADRS score \>4 on question #10 or Columbia Suicide Severity Scale (C-SSRS), yes response to Question #4 (ideation, intent, but no plan) or Question #5 (ideation, intent, and plan).
Any current drug and alcohol use disorder (excluding nicotine); complete (not partial) remission ≥3 months.
Positive toxicology screen for cannabis and cannabis use disorder by structured clinical interview. Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included if the Cannabis Use Disorder Identification Test (CUDIT-R) score is \< 12.
Currently undergoing ECT, transcranial magnetic stimulation, or deep brain stimulation as an acute or maintenance treatment. Maintenance vagal nerve stimulation is allowed if the placement of device is \> 1 year.
Current involuntary psychiatric hospitalization.
Already in ketosis or on a medication that causes acidosis, such as carbonic anhydrase inhibitors (e.g., acetazolamide "Diamox" and topiramate).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mayo Clinic in Rochester — Rochester, Minnesota

📞 Contact the Study Coordinator

Phone: (507) 293-3876

Email: Lindstrom.Karin@mayo.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression — Tulsa, Oklahoma

Explore by condition: All Bipolar Depression clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗