Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

Summary

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.

Conditions

• Bipolar Disorder (BD)
• Bipolar Disorder NOS
• Bipolar Disorder I or II
• Bipolar Spectrum Disorder
• Adolescents

Interventions

OTHER

Ketogenic Therapy

During the keto therapy (16 weeks), the youth will participate in a strict ketogenic diet, with adjustments made as necessary from weekly dietitian coaching sessions.

Sponsors & Collaborators

• University of Cincinnati

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Advanced Ketogenic Therapies

  collaborator UNKNOWN

• Baszucki Family Foundation

  collaborator UNKNOWN

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-19

Primary Completion

2027-03-19

Completion

2027-03-19

Countries

• United States

Study Locations