Theta burst magnetic stimulation with medicine for depression not helped by antidepressants
Tests magnetic brain stimulation added to antidepressants in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Asan Medical CenterSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jung-Sun Lee
- Trial code
- NCT07529574
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Metal implants or contraindications to TMS; Prior rTMS or ECT; Bipolar disorder, schizophrenia, or psychotic disorder; Substance use disorder (recent); Neurological disorders (e.g., epilepsy, brain injury); Severe medical illness; Any condition deemed unsuitable by investigator; Pacemaker or implanted device; Pregnancy.