Ketogenic Diet and Neuromodulation in Treatment Resistant Depression

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
The goal of this clinical trial is to test whether combining a ketogenic diet (KD) with personalized, accelerated intermittent theta burst stimulation (iTBS) produces greater reductions in depressive symptoms than iTBS combined with a standard healthy diet in adults with treatment-resistant depression. The trial also aims to determine whether participants can feasibly follow a ketogenic diet during an accelerated iTBS treatment course and whether the diet produces measurable changes in ketone levels. Specifically, the study aims to determine whether the combined intervention: 1. Reduces depressive symptoms 2. Increases circulating ketone levels 3. Is feasible and tolerable during accelerated iTBS treatment Participants will begin either a KD or a Canadian Food Guide-aligned diet (CFGD) with a 3-week dietary lead-in period, after which they will undergo a course of personalized, accelerated iTBS while continuing their assigned diet. Before and after the iTBS treatment course, participants will complete clinical assessments, provide blood samples for metabolic testing, and undergo MRI scans to assess brain connectivity. Ketone levels will be measured daily throughout the 12-week dietary intervention. Within-group and between-group differences will be compared to characterize changes in clinical outcomes, metabolism, and brain functioning.
Epistemonikos ID: 620f20bb28dad6d3416af54410c398e940810f34
First added on: Jan 30, 2026