Actively Recruiting

Phase Not Applicable
Age: 12Years - 21Years
All Genders
ID06920940

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

Led by University of California, Los Angeles · Updated on 2026-04-22

80

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

U

University of Cincinnati

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a ketogenic diet combined with standard medication in adolescents and young adults aged 12 to 21 who are experiencing depressive or mixed phases of bipolar disorder. This open trial aims to determine if adding a 16-week ketogenic diet to usual pharmacological treatments is well-tolerated and linked to improvements in depression, inflammation, metabolism, and executive functioning. The study involves 80 youth from four sites, focusing on feasibility, adherence, and potential symptom and health benefits. Participants follow a strict ketogenic diet for 16 weeks, with weekly coaching from dietitians who help with meal planning and monitor dietary intake, ketone levels, and side effects. The study includes a 4-week intake and assessment phase, a 2-3 week diet ramp-up period where participants gradually increase keto meals, the main 16-week ketogenic therapy phase, and a final post-treatment evaluation week. Youth receive standard psychiatric care throughout, including medication management and side effect monitoring by study psychiatrists. During the study, participants undergo regular assessments including blood tests for metabolic and inflammatory markers, monthly symptom evaluations, and cognitive testing. They use a blood ketone meter daily to track ketosis, with data shared securely with the study team. Monthly visits with psychiatrists and weekly dietitian sessions support safety and adherence. Outcome measures include diet adherence, symptom changes, metabolic health, and functioning, with the total participation lasting about 23 weeks including all phases.

CONDITIONS

Brief Title

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

Who Can Participate

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth aged 12 to 21 years who speak English
  • Suitable for outpatient treatment; not acutely psychotic, suicidal, or manic
  • Diagnosed with bipolar I, II, or other specified bipolar spectrum disorder
  • Active depressive or mixed symptoms with specific severity ratings
  • Willing to participate in psychiatric and dietitian visits for evaluation and medication management
  • For minors, at least one English-speaking parent or guardian must consent and be available
  • Youth and caregivers willing to try ketogenic therapy and adhere to study protocol
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Underweight (BMI below 18.5) or wasting syndrome
  • Current or past anorexia nervosa or current bulimia/binge eating disorder
  • Autism spectrum disorder level 2 or higher
  • History of cardiac issues, arrhythmia, cardiovascular or cerebrovascular disease
  • Type I or II diabetes
  • History of seizures or epilepsy
  • History of stroke or cancer
  • Unstable respiratory conditions
  • Severe gastroesophageal reflux disease despite medication
  • Substance use disorder except mild cannabis or nicotine use
  • History of kidney stones or disease
  • Diseases of pancreas, liver, gallbladder, or thyroid
  • High cholesterol or triglycerides requiring physician review
  • Genetic metabolic disorders affecting ketone processing
  • Current use of certain diabetes or antihypertensive medications (SGLT-2 inhibitors, insulin, sulfonylureas, ACE inhibitors, ARBs, spironolactone, thiazide diuretics)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Initial phone screen followed by in-person consenting and psychiatric evaluation visits

Ketogenic Preparation and Ramp Up

Duration - 2 to 3 weeks

Participants prepare for the ketogenic diet by gradually introducing keto meals and completing pre-diet assessments including mood, functioning, and neuropsychological testing.

Weekly visits with the dietitian

Ketogenic Therapy

Duration - 16 weeks

Participants follow a strict ketogenic diet for 16 weeks with weekly dietitian coaching and daily self-administered blood ketone and glucose testing to maintain ketosis. Monthly psychiatric visits support medication management and safety monitoring.

Weekly dietitian visits, daily self-testing, and monthly psychiatrist visits

Post-Treatment Assessments

Duration - 1 week

Participants complete post-treatment evaluations including symptom assessments, neuropsychological testing, and psychosocial functioning measures.

1 to 2 visits for final assessments

Trial Site Locations

Total: 4 locations

1

UCLA Semel Institute Max Gray Child and Adolescent Mood Disorders Program (CHAMP)

Los Angeles, California, United States, 90024

Actively Recruiting

2

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Not Yet Recruiting

3

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States, 45267

Actively Recruiting

4

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

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Research Team

D

David J Miklowitz, Ph.D.

D

Danielle M Denenny, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

Lakshmi N Yatham, Sidney H Kennedy, Sagar V Parikh...

https://pubmed.ncbi.nlm.nih.gov/29536616

Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet Among Children With Drug-Resistant Epilepsy: A Randomized Clinical Trial.

Vishal Sondhi, Anuja Agarwala, Ravindra M Pandey...

https://pubmed.ncbi.nlm.nih.gov/32761191

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

David J Miklowitz, Christopher D Schneck, Patricia D Walshaw...

https://pubmed.ncbi.nlm.nih.gov/31940011

Pharmacotherapy and family-focused treatment for adolescents with bipolar I and II disorders: a 2-year randomized trial.

David J Miklowitz, Christopher D Schneck, Elizabeth L George...

https://pubmed.ncbi.nlm.nih.gov/24626789

Optimal clinical management of children receiving dietary therapies for epilepsy: Updated recommendations of the International Ketogenic Diet Study Group.

Eric H Kossoff, Beth A Zupec-Kania, Stéphane Auvin...

https://pubmed.ncbi.nlm.nih.gov/29881797

Inflammation and oxidative stress in epileptic children: from molecular mechanisms to clinical application of ketogenic diet.

Azam Ildarabadi, Seyedeh Nooshan Mir Mohammad Ali, Fatemeh Rahmani...

https://pubmed.ncbi.nlm.nih.gov/38347675