NCT07529574Not yet recruiting
Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
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
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 5 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jung-Sun Lee
- Diseases
- Depression
- NCT number
- NCT07529574
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Metal implants or contraindications to TMS
- Prior rTMS or ECT
Other illness
- 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
Other
- Pacemaker or implanted device
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.