Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression

This study will evaluate the efficacy and safety of a theta burst stimulation (TBS) protocol of repetitive transcranial magnetic stimulation (rTMS) in adults with treatment-resistant depression. Participants will be randomized to either antidepressant treatment plus active rTMS TBS or antidepressant treatment plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions. The main objective is to compare the change in Hamilton Depression Rating Scale (HAM-D) total score after 10 treatment sessions between groups and to explore predictors of treatment response.

NCT Number	NCT07529574
Lead Sponsor	Jung-Sun Lee Collaborators: Korea Health Industry Development Institute, Seoul National University Hospital, Nowon Eulji Medical Center, Seoul St. Mary's Hospital
Conditions	Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
Enrollment	120 participants
Start Date	2026-05-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-14