Condition: Bipolar Disorder (BD) · Bipolar Disorder NOS · Bipolar Disorder I or II · Sponsor: University of California, Los Angeles
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…
This description comes directly from the study's public registry record.
David J Miklowitz, Ph.D. · 310-267-2659 · dmiklowitz@mednet.ucla.edu
Danielle M Denenny, Ph.D. · 310-825-8740 · ddenenny@mednet.ucla.edu
Always discuss trial participation with your own doctor first.
| UCLA Semel Institute Max Gray Child and Adolescent Mood Disorders Program (CHAMP) | Los Angeles, California, United States | Recruiting |
| University of Colorado Denver, Anschutz Medical Campus | Aurora, Colorado, United States | Not Yet Recruiting |
| University of Cincinnati College of Medicine | Cincinnati, Ohio, United States | Recruiting |
| University of Pittsburgh School of Medicine | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06920940