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

NCT07529574 | Not Yet Recruiting

• 1 other identifier: 2025-0378
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

depression; major depressive disorder; Repetitive Transcranial Magnetic Stimulation; Theta Burst Stimulation

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and at 10 treatment sessions (~ 2 weeks)

Study Arms (2)

Antidepressant + Active rTMS TBS

EXPERIMENTAL

Drug: antidepressant therapy; Device: Active rTMS Theta Burst Stimulation

Antidepressant + Sham then Active rTMS TBS

SHAM COMPARATOR

Drug: antidepressant therapy; Device: Sham Stimulation

Interventions

antidepressant therapy DRUG

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

Antidepressant + Active rTMS TBS; Antidepressant + Sham then Active rTMS TBS

Active rTMS Theta Burst Stimulation DEVICE

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

Antidepressant + Active rTMS TBS

Sham Stimulation DEVICE

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.

Antidepressant + Sham then Active rTMS TBS

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jung-Sun Lee: lead
• Korea Health Industry Development Institute: collaborator
• Seoul National University Hospital: collaborator
• Nowon Eulji Medical Center, Eulji University: collaborator
• Seoul St. Mary's Hospital, The Catholic University: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05530, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jungsun Lee, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jungsun Lee, MD, PhD

CONTACT

+82-2-3010-3422; ljssmh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

KR (1)