Clinical Trial

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Recruiting
View on ClinicalTrials.gov →
Summary
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-01-23; most recent amendment 2025-11-04.
Status change: Not Yet Recruiting → Recruiting 2024-03-06
Trial Details
NCT Number NCT06221852
Lead Sponsor Mclean Hospital
Collaborators: Baszucki Family Foundation
Conditions Bipolar I Disorder, Psychosis, Schizoaffective Disorder
Enrollment 50 participants
Start Date 2024-03-12
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-05