Ketogenic Intervention for Bipolar Depression

NCT07121894 | Recruiting DMC

• 1 other identifier: 24-013228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms

  Measured using the Quick Inventory for Depressive Symptomatology Clinician Rated (QIDS-C), a 16-item clinician rating, each rated on a four-point Likert scale (0-3). The total score ranges from 0 to 27. The QIDS-C is scored by summing the responses to the 16 items, with higher scores indicating more severe symptoms.

  Baseline, 6 months

Secondary Outcomes (11)

• Response and Remission Rates

  Baseline, 6 months

• Percentage of clinically significant improvement

  Baseline, 6 months

• Change in anxiety symptoms

  Baseline, 6 months

• Prevalence rate of disordered eating

  6 months

• Change in psychosocial functioning

  Baseline, 6 months

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Patients diagnosed with bipolar disorder and experiencing depression or depressive symptoms.

Behavioral: Ketogenic Diet

Interventions

Ketogenic Diet BEHAVIORAL

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.

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• BMI \< 18.5; (m) baseline LDL-c \> 190.
• Acute pancreatitis or history of lipid-associated pancreatitis.
• Type I diabetes.
• SGLT2 inhibitor use

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kyla M. Lara-Breitinger, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Mark Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Lindstrom, PhD

CONTACT

507-293-3876; Lindstrom.Karin@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 14, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)