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Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
Sponsor: Jung-Sun Lee
Summary
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.
Official title: A Prospective, Multicenter, Randomized, Single-Blind, Exploratory Clinical Trial to Validate the Efficacy and Safety and Predict Treatment Response of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-05-01
Completion Date
2027-12-31
Last Updated
2026-04-14
Healthy Volunteers
No
Interventions
antidepressant therapy
Participants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons.
Active rTMS Theta Burst Stimulation
Bilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions.
Sham Stimulation
Sham stimulation is delivered for the first 10 sessions using coil positioning that prevents effective stimulation, followed by active rTMS TBS for the next 10 sessions.
Locations (1)
Asan Medical Center
Seoul, South Korea