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

NCT07529574 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

  • Major Depressive Disorder (MDD)
  • Depression - Major Depressive Disorder

Interventions

DRUG

antidepressant therapy

Participants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons.

DEVICE

Active rTMS Theta Burst Stimulation

Bilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions.

DEVICE

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.

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Seoul National University Hospital

    collaborator OTHER

  • Nowon Eulji Medical Center, Eulji University

    collaborator UNKNOWN

  • Seoul St. Mary's Hospital, The Catholic University

    collaborator UNKNOWN

  • Jung-Sun Lee

    lead OTHER

Principal Investigators

  • Jungsun Lee, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529574 on ClinicalTrials.gov