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

NCT07529574 · tracked via the Priya Life Science South Korea tracker

Sponsor

Jung-Sun Lee

Phase

Not applicable

Started

2026-05-01

Last updated

2026-04-14

Condition(s) studied

Major Depressive Disorder (MDD)Depression - Major Depressive Disorder

Investigational drug(s) / intervention(s)

antidepressant therapyActive rTMS Theta Burst StimulationSham Stimulation

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.

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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)

Trial sites (1)

Facility	City	Region	Status
Asan Medical Center	Seoul	South Korea

Other trials for the same condition

Digital Phenotypes for Predicting Depression Enrolling by invitation

Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07529574 on ClinicalTrials.gov ↗ ← All trials in South Korea