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NCT Number: NCT07529574

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

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depression - Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antidepressant Therapy

Drug

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

Active rTMS Theta Burst Stimulation

Device

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

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.

Primary outcomes

  1. Change in Depressive Symptom Severity

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jungsun Lee, MD, PhD

CONTACT

[email protected]

+82-2-3010-3422

Sponsors and collaborators

Lead sponsor

Jung-Sun Lee

Other

Collaborators

  • Korea Health Industry Development Institute
  • Nowon Eulji Medical Center
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital

Registry information

Official study title

A Prospective, Multicenter, Randomized, Single-Blind, Exploratory Clinical Trial to Validate the Efficacy and Safety and Predict Treatment Response of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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