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Clinical trialNCT06920940RecruitingInterventional

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

SponsorUniversity of California, Los AngelesEnrollment80AdolescentsBipolar Disorder (BD)Bipolar Disorder I or IIBipolar Disorder NOSBipolar Spectrum Disorder
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The present study is an open trial of ketogenic diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). The investigators aim to determine whether combining standard of care pharmacological treatment for bipolar spectrum disorders with a 16-week ketogenic diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning over the study period. The experimental treatment in this study is a 16-week full ketogenic diet. Four study sites (UCLA, U Cincinnati, U Colorado and U Pittsburgh) will recruit 80 total youth (20 each) from bipolar specialty clinics. All youth eligible for the ketogenic therapy will be provided with the ketogenic diet and standard of care pharmacological treatment. During the diet therapy youth will be seen by a study child/adolescent psychiatrist at least once a month (and more frequently when needed), with the psychiatrist recommending and providing side effects monitoring and pharmacotherapy as clinically indicated. The youth and caregivers will also meet with an expert dietitian who will coach all youth on maintaining the ketogenic diet (low carbs, high fats, medium protein) and making sure the child is tolerating the diet and getting enough liquid and nutrients, following the practice guidelines of the International Ketogenic Diet Study Group for treating youth. All youth and involved caregivers will also be provided will at least one motivational enhancement session to support them in goal setting and completion of the study elements. Throughout the study the investigators will assess metabolic (e.g., blood ketones, HOMA-IR) and inflammatory indicators (e.g., C-reactive protein), both for safety reasons and to assess correlates of symptomatic change. Independent evaluators will assess youth every month regarding their symptoms (depression, mania, anxiety, psychosis), psychosocial functioning, and quality of life. The investigators anticipate that the pilot will transpire over 24 months and be an important step toward establishing feasibility and acceptability of ketogenic therapy for this population, not only in terms of diet administration and compliance but also for obtaining symptomatic, metabolic and inflammatory measurements.

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ucla Semel Institute Max Gray Child and Adolescent Mood Disorders Program (champ)

    Los Angeles, California, United States

    Danielle M Denenny, Ph.D.David J Miklowitz, Ph.D.Elizabeth A Horstmann, M.D.Madeline O Jansen, M.D.Megan C Ichinose, Ph.D.Patricia D Walshaw, Ph.D.
    Recruiting
  • University of Colorado Denver, Anschutz Medical Campus

    Aurora, Colorado, United States

    Aimee Sullivan, Ph.D.Christopher Schneck, M.D.Melissa Batt, M.D.
    Not, yet, recruiting
  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, United States

    Melissa Delbello, M.D.Rodrigo Patino Duran, M.D.
    Recruiting
  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, United States

    Boris Birmaher, M.D.Danella Hafeman, M.D.
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Mar 2025
Primary completion
19 Mar 2027
Completion
19 Mar 2027
Last update posted
22 Apr 2026
Registered enrollment
80
Registry id
NCT06920940

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.