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Ketogenic Diet for Bipolar Disorder in Adolescents

This study is looking at whether a 16-week ketogenic diet, combined with usual medical care, can help teenagers and young adults (ages 12-21) with bipolar disorder. Specifically, it focuses on those experiencing depression or mixed symptoms. Researchers want to see if the ketogenic diet is well-tolerated and if it helps improve depression symptoms. You might be able to join if you are 12-21 years old, speak English, and have a diagnosis of bipolar disorder (including Bipolar I, II, or other specified Bipolar Spectrum Disorder). The study will enroll 80 participants across four different locations.

Study design
This is an open trial, meaning everyone knows they are receiving the ketogenic diet. It plans to enroll 80 participants.
What's involved
You would participate in a strict ketogenic diet for 16 weeks, with weekly coaching sessions from a dietitian. There will also be an initial 4-week evaluation period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for diet adherence, diet tolerance, and depression symptom improvement are measured from the start of the ketogenic therapy to the end of treatment (up to 16 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06920940

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents

Recruiting
NAAges 12–21InterventionalTreatment
University of California, Los Angeles
~80 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Ketogenic Therapy

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diet Adherence
Measured over From initiation of ketogenic therapy to the end of treatment (up to 16 weeks)
+4 more outcomes measured

Conditions

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

Explore related trials

Bipolar Disorder

Where it's being run

4 sites across 4 states
California1
Colorado1
Ohio1
Pennsylvania1

Who to contact

David J Miklowitz, Ph.D.
[email protected]
310-267-2659
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Youth must be ages 12 to 21 years old and speak English
Youth must be appropriate for outpatient treatment (i.e., not a danger to self or others; not acutely psychotic, suicidal or manic; not in need of partial or full hospitalization)
Youth must have a current BSD (bipolar I, II per DSM-5 criteria (Association, 2013) or other specified BSD by the University of Pittsburgh diagnostic criteria (Birmaher et al., 2006). The Pittsburgh other specified BSD criteria require recurrent and distinct 1-3 day periods (minimum 4 hours/day) in which there has been abnormally elevated, expansive, or irritable mood plus two (three, if irritable mood only) symptoms of mania that caused a change in functioning and totaled at least 4 days in the child's lifetime
Active symptoms: In the 2 weeks prior to study intake, participants must have had weekly depression Psychiatric Status Ratings (PSRs) of 3 (moderate) or higher (using the 1-6 depression severity scales from the Adolescent Longitudinal Follow-up Evaluation, or A-LIFE); or an interview-based Children's Depression Rating Scale, Revised (CDRS-R) score covering the prior 2 weeks of \> 20. Youth may also enter with mixed symptoms (e.g., simultaneous elevations of \> 3 on the PSR depression and hypomania scales, with Young Mania Rating Scale scores of 12 or higher), without meeting criteria for a full manic episode in the past month.
Participants must continue to meet the study's active symptom criteria when beginning the phase II keto "ramp-up" phase: a depression PSR rating of 3 or higher over the prior 2 weeks, and a CDRS-R score covering the prior 2 weeks of \> 20.
Youth/parents must be willing to participate in evaluation and medication management sessions with a study psychiatrist and the study dietitian for assessment of the diet and side effects.
Youth under 18 years old must have at least one English-speaking parent or other caregiving family member consenting to participate in the study and available for consultation if needed
Youth and (for minors) all parents/legal guardians with health care decision making rights must express willingness to have the youth be in the study and try the keto therapy, assuming that the youth is eligible. The team must ascertain that the participating minor's youth/caregiver is likely to make a strong effort to adhere to the study's protocol.

Exclusion

pregnancy or breastfeeding
underweight (BMI below 18.5) or wasting syndrome (e.g., anorexia cachexia)
current or history of anorexia nervosa
current disordered eating (bulimia or binge eating disorder)
autism spectrum disorder diagnosis level 2 or greater (more than mild)
cardiac issues, including history of arrhythmia, or cardiovascular or cerebrovascular disease
type I and type II diabetes
history of seizures/epilepsy
history of stroke or cancer
unstable respiratory condition
severe gastroesophageal reflux (GERD; painful/impairing despite prescription medication)
substance use disorder (with an exception for mild cannabis or nicotine use disorders)
history of kidney stones/disease
diseases involving the pancreas, liver, gallbladder or thyroid, including Von Gierke's glycogen storage disease
Condition with high cholesterol of triglycerides will prompt physician review of eligibility (LDL\>190 or triglycerides\>500)
genetic metabolic disorders: either porphyria (impacting the body's ability to make hemoglobin) or fatty acid oxidation disorder (FAOD)
rare conditions of defective ketone production or breakdown (carnitine deficiency, carnitine palmitoyl-transferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, Succinyl-CoA:3-ketoacid CoA transferase deficiency (SCOT), or pyruvate carboxylase deficiency)
youth must not be taking SGLT-2 inhibitors (e.g., canagliflozin), insulin, or sulfonylureas (to avoid hypogycemia), or Antihypertensive medication (e.g., lisinopril/ACE Angiotensin inhibitors ending in "pril", ARB Angiotensin II receptor blockers, spironolactone/Aldactone, Thiazide-type diuretics)

What this trial measures

  • Diet AdherenceFrom initiation of ketogenic therapy to the end of treatment (up to 16 weeks)

    The investigators will assess diet adherence primarily by the proportion of youth who maintain an average weekly ketone level of 1 mmol/L or above, as measured through daily blood ketone assays using the Keto Mojo device, a Bluetooth-enabled ketone and glucose testing kit.

  • Diet ToleranceFrom initiation of ketogenic therapy to the end of treatment (up to 16 weeks)

    The investigators will assess diet tolerance primarily by calculating the proportion of youth staying on the diet. The investigators hypothesize 70-80% of youth will tolerate staying on the keto therapy throughout the 16-week treatment as verified by youth self report of continuance of the diet (combined with parent report if applicable). Youth with multiple weekly ketone levels at .5 mmol/L or below will be considered diet intolerant regardless of self-report.

  • Depression Symptom ImprovementFrom initiation of ketogenic therapy to the end of treatment (up to 16 weeks)

    The investigators hypothesize that youth who complied with the 16-week keto diet therapy will show statistically significant reductions in depressive symptoms from baseline to completion of the diet. Depressive symptoms will primarily be captured using the clinician-rated Children's Depression Rating Scale, Revised (CDRS-R). Scores range from 17 to 113, with higher scores indicating greater pathology or severity of depressive symptoms (worse outcome).

  • Bipolar Symptom ImprovementFrom initiation of ketogenic therapy to the end of treatment (up to 16 weeks)

    The investigators hypothesize that youth who complied with the 16-week keto diet therapy will show statistically significant reductions in bipolar mood instability from baseline to completion of the diet. Bipolar instability will primarily be captured using the clinician-rated Clinical Global Impression - Bipolar Disorder Severity Scale (CGI-BP). CGI-BP overall psychiatric illness scores range from 1 (normal, best outcome) to 7 (very severely ill, worse outcome) and capture severity of bipolar symptoms over the worst 7-day period in the past 2 weeks.

  • HOMA - IR Metabolic IndicatorFrom initiation of ketogenic therapy to the end of treatment (up to 16 weeks)

    The investigators hypothesize that youth with high compliance with the keto diet will show significant pre- to post-treatment improvement in Homeostatic model assessment for insulin resistance (HOMA - IR). HOMA - IR is calculated based on fasting glucose and insulin measurements and a value greater than 2 indicates insulin resistance (worse outcome) while a value less than 1 indicates normal range insulin sensitivity (better outcome).