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NCT06920940 · ClinicalTrials.gov registry record · NA
Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents
A NA study of Adolescents and Bipolar Disorder I or II, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT06920940 is a NA study of Adolescents and Bipolar Disorder I or II that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 80 participants, below the 3,643-participant average among 7 other Adolescents trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06920940, a NA study of Adolescents and Bipolar Disorder I or II, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Ketogenic Therapy
Study Locations (4)
California
- UCLA Semel Institute Max Gray Child and Adolescent Mood Disorders Program (CHAMP) - Los Angeles
Colorado
- University of Colorado Denver, Anschutz Medical Campus - Aurora
Ohio
- University of Cincinnati College of Medicine - Cincinnati
Pennsylvania
- University of Pittsburgh School of Medicine - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-03-19 |
| Est. Completion | 2027-03-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06920940
The ClinicalTrials.gov registry entry for NCT06920940 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,643-participant average among 7 other Adolescents trials with a reported enrollment target (98% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Adolescents appearing as the primary indexed condition, and to 1 intervention - of which Ketogenic Therapy is the first listed.
NCT06920940 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT06920940 about?
NCT06920940 is a clinical study titled "Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents". 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...
What is the current status of trial NCT06920940?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-03-19. Estimated completion is 2027-03-19.
What conditions does trial NCT06920940 study?
This clinical trial studies the following conditions: Adolescents, Bipolar Disorder I or II, Bipolar Disorder NOS, Bipolar Disorder (BD), Bipolar Spectrum Disorder.
What interventions are being tested in trial NCT06920940?
The interventions under investigation include: Ketogenic Therapy (OTHER).
Who is sponsoring clinical trial NCT06920940?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06920940 being conducted?
This trial has 4 study locations across California, Colorado, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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