An interventional study of antidepressant therapy and Active rTMS Theta Burst Stimulation in Major Depressive Disorder (MDD) and Depression - Major Depressive Disorder, sponsored by Jung-Sun Lee. Not yet recruiting at 1 site in South Korea. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Jung-Sun Lee · Not applicable, Interventional, and Treatment
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.
This is a prospective, multicenter, randomized, double-blind, exploratory clinical trial evaluating the efficacy and safety of rTMS theta burst stimulation (TBS) in patients with depression.
A total of 120 participants will be enrolled, including 80 adults (≥19 years) with treatment-resistant depression and 40 adolescents (15-17 years) with depressive disorders. Participants will be stratified by age group and randomized in a 1:1 ratio to one of two treatment arms.
In the combined treatment arm, participants will receive antidepressant therapy plus active bilateral sequential TBS (bsTBS) for 20 sessions over approximately 4 to 7 weeks. In the comparator arm, participants will receive antidepressant therapy plus sham stimulation for the first 10 sessions, followed by active TBS for the remaining 10 sessions.
The primary outcome is the change in depressive symptom severity after 10 treatment sessions, measured by HAM-D in adults and age-appropriate scales in adolescents. Secondary outcomes include sleep, cognitive function, global clinical improvement, social functioning, and neuroimaging biomarkers. Safety outcomes include adverse events and suicidal ideation assessments.
This study aims to explore the efficacy of TBS across different age groups and to identify predictors of treatment response.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →This is the only study on the registry with Jung-Sun Lee as lead sponsor.
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Exclusion Criteria:
Drug: antidepressant therapy · Device: Active rTMS Theta Burst Stimulation
Drug: antidepressant therapy · Device: Sham Stimulation
Participants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons.
Bilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions.
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.
Change in Depressive Symptom Severity
Change in depressive symptom severity measured by the Hamilton Depression Rating Scale (HAM-D; range 0-52, higher scores indicate more severe depression)
Time frame: Baseline and at 10 treatment sessions (~ 2 weeks)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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