Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
Starting soon · Not applicable · Has a placebo group
Conditions studied: Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT07529574
- Run by
- Jung-Sun Lee
- People needed
- 120
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-04-14
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Asan Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.