RECRUITING

Ketogenic Intervention for Bipolar Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-12

Study Completion:2029-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07121894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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, vagal nerve stimulation, or deep brain stimulation as an acute or maintenance treatment. * Current involuntary psychiatric hospitalization. * Already on a ketogenic diet or on a medication that causes acidosis, such as carbonic anhydrase inhibitors (e.g., acetazolamide "Diamox" and topiramate). * BMI \< 18.5; (m) baseline LDL-c \> 190. * Any active or unstable medical condition judged by the principal investigator as conferring significant medical risk to allow inclusion in the study, such as active severe infection * Acute pancreatitis or history of lipid-associated pancreatitis * Type I diabetes. * SGLT2 inhibitor use * Rare inborn errors of metabolism affecting fatty acid processing (typically diagnosed in infancy or, rarely, adolescence), such as Pyruvate carboxylase deficiency and Porphyria * Primary carnitine deficiency * Chronic renal failure, significant renal disease defined as creatinine clearance \<30 or in dialysis. * Severe vitamin D deficiency (serum levels of 25-hydroxyvitamin D \[25(OH)D\] \< 10 ng/mL). * A diagnosis of osteopenia, defined as a bone mineral density (BMD) T-score between -1.0 and -2.5 on a dual-energy X-ray absorptiometry (DEXA) scan or with a history of fragility fractures * Clinically significant laboratory test abnormality * Anticipated elective surgical procedure within the next 20 weeks * Family history of premature coronary artery disease defined as atherosclerotic cardiovascular events (e.g., heart attack, stroke..) before 55 and 65 years of age in male and female first-degree relatives, respectively. * History of familial hypercholesterolemia (note -current or start of statin or lipid-lowering drug as part of clinical care is not an exclusion provided managed by a primary care provider) or cholesterol more than 240 mg/dL / 6.2 mmol/L. * History of coronary disease or coronary calcifications or coronary stenosis found in invasive cardiac catheterization, or imaging. * History of ischemic stroke or carotid plaque found on baseline common carotid intima-media thickness (IMT) ultrasound. * History of peripheral atherosclerotic arterial disease or any other form of clinical atherosclerosis. * History or current diagnosis of respiratory failure defined as a PaO₂ \< 60 mmHg or SpO₂ \< 90% on room air or any condition leading to clinically significant respiratory impairment * History or current diagnosis of liver failure or chronic liver disease with significant impairment, defined as ALT or AST \> 5 times the upper limit of normal, or total bilirubin \> 3 mg/dL

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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, vagal nerve stimulation, or deep brain stimulation as an acute or maintenance treatment.
* Current involuntary psychiatric hospitalization.
* Already on a ketogenic diet or on a medication that causes acidosis, such as carbonic anhydrase inhibitors (e.g., acetazolamide "Diamox" and topiramate).
* BMI \< 18.5; (m) baseline LDL-c \> 190.
* Any active or unstable medical condition judged by the principal investigator as conferring significant medical risk to allow inclusion in the study, such as active severe infection
* Acute pancreatitis or history of lipid-associated pancreatitis
* Type I diabetes.
* SGLT2 inhibitor use
* Rare inborn errors of metabolism affecting fatty acid processing (typically diagnosed in infancy or, rarely, adolescence), such as Pyruvate carboxylase deficiency and Porphyria
* Primary carnitine deficiency
* Chronic renal failure, significant renal disease defined as creatinine clearance \<30 or in dialysis.
* Severe vitamin D deficiency (serum levels of 25-hydroxyvitamin D \[25(OH)D\] \< 10 ng/mL).
* A diagnosis of osteopenia, defined as a bone mineral density (BMD) T-score between -1.0 and -2.5 on a dual-energy X-ray absorptiometry (DEXA) scan or with a history of fragility fractures
* Clinically significant laboratory test abnormality
* Anticipated elective surgical procedure within the next 20 weeks
* Family history of premature coronary artery disease defined as atherosclerotic cardiovascular events (e.g., heart attack, stroke..) before 55 and 65 years of age in male and female first-degree relatives, respectively.
* History of familial hypercholesterolemia (note -current or start of statin or lipid-lowering drug as part of clinical care is not an exclusion provided managed by a primary care provider) or cholesterol more than 240 mg/dL / 6.2 mmol/L.
* History of coronary disease or coronary calcifications or coronary stenosis found in invasive cardiac catheterization, or imaging.
* History of ischemic stroke or carotid plaque found on baseline common carotid intima-media thickness (IMT) ultrasound.
* History of peripheral atherosclerotic arterial disease or any other form of clinical atherosclerosis.
* History or current diagnosis of respiratory failure defined as a PaO₂ \< 60 mmHg or SpO₂ \< 90% on room air or any condition leading to clinically significant respiratory impairment
* History or current diagnosis of liver failure or chronic liver disease with significant impairment, defined as ALT or AST \> 5 times the upper limit of normal, or total bilirubin \> 3 mg/dL

Contacts and Locations

Study Contact

Karin Lindstrom, PhD

CONTACT

507-293-3876

Lindstrom.Karin@mayo.edu

Principal Investigator

Kyla M. Lara-Breitinger, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Kyla M. Lara-Breitinger, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12

Study Completion Date2029-05-01

Study Record Updates

Study Start Date2025-08-12

Study Completion Date2029-05-01

Terms related to this study

Additional Relevant MeSH Terms

Bipolar Depression