Ketogenic Diet Treatment for Adolescents with Bipolar Disorder A 16-Week Study Combining Diet and Medication for Mood Improvement

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.

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents