Depression - Major Depressive Disorder, Major Depressive Disorder (MDD)
Conditions
Keywords
depression, major depressive disorder, Repetitive Transcranial Magnetic Stimulation, Theta Burst Stimulation
Brief 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.
Detailed description
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.
Interventions
Participants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons.
DEVICEActive rTMS Theta Burst Stimulation
Bilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions.
DEVICESham 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.
Sponsors
Jung-Sun Lee
Korea Health Industry Development Institute
Seoul National University Hospital
Nowon Eulji Medical Center, Eulji University
Seoul St. Mary's Hospital, The Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a double-blind study for participants and outcome assessors. Stimulation settings are managed separately by designated personnel according to pre-specified conditions so that participants and assessors remain blinded, particularly through the primary endpoint assessment after 10 treatment sessions.
Intervention model description
Participants are randomized 1:1 to antidepressant monotherapy plus active rTMS TBS or antidepressant monotherapy plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥15 years * Diagnosis of depressive disorder based on DSM criteria * Adults: treatment-resistant depression * Adolescents: depressive disorder requiring treatment * Moderate or greater depressive symptoms * Adults: HAM-D ≥17, MADRS ≥14 * Adolescents: age-appropriate validated scale (e.g., CDRS-R) * Currently receiving or eligible for antidepressant treatment
Exclusion criteria
* Bipolar disorder, schizophrenia, or psychotic disorder * Substance use disorder (recent) * Neurological disorders (e.g., epilepsy, brain injury) * Severe medical illness * Metal implants or contraindications to TMS * Pacemaker or implanted device * Prior rTMS or ECT * Pregnancy * Any condition deemed unsuitable by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptom Severity | Baseline and at 10 treatment sessions (~ 2 weeks) | Change in depressive symptom severity measured by the Hamilton Depression Rating Scale (HAM-D; range 0-52, higher scores indicate more severe depression) |
Countries
South Korea
Contacts
CONTACTJungsun Lee, MD, PhD
PRINCIPAL_INVESTIGATORJungsun Lee, MD, PhD
Asan Medical Center
Outcome results
None listed