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Not yet recruiting NCT07529574

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

No phase Interventional Major Depressive Disorder (MDD) Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antidepressant therapy, Active rTMS Theta Burst Stimulation, Sham Stimulation.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), Depression - Major Depressive Disorder. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • 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.

Primary outcome measures

  • Change in Depressive Symptom Severity [Time frame: Baseline and at 10 treatment sessions (~ 2 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT07529574 · 2025-0378

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗