Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Ketogenic Therapy — OTHER
  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.

Study Details

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.

Key Dates

Start date

Mar 19, 2025

Status verified

Apr 2026

Primary completion

Mar 19, 2027

Completion

Mar 19, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ketogenic Therapy for Bipolar Spectrum Disorders
  This is a pilot trial with one intervention arm. All youth meeting eligibility for the ketogenic therapy phase of this pilot trial will be invited to participate in the intervention and progress tracking.

Primary Outcome Measure

Diet Adherence [ Time Frame: From initiation of ketogenic therapy to the end of treatment (up to 16 weeks) ]

Central Contacts

• David J Miklowitz, Ph.D.
  310-267-2659
  [email protected]
• Danielle M Denenny, Ph.D.
  310-825-8740
  [email protected]

Locations (4)

Find similar trials in Los Angeles, CA

Related Studies

• Centralized Virtual SBIRT for Pediatric Primary Care
  Recruiting · Kaiser Permanente · Pleasanton, California
• Mental Health, Intellectual and Neurodevelopmental Disorder Detection With Artificial Intelligence Models
  Enrolling By Invitation · Psyrin Inc. · Brookline, Massachusetts
• Healthy Children and Virtual Reality Mediation of Simulated Pain
  Enrolling By Invitation · Nationwide Children's Hospital · Columbus, Ohio
• Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
  Enrolling By Invitation · Stanford University · Pittsburgh, Pennsylvania