Major Depressive Disorder (MDD)NCT07529574
Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
A study testing antidepressant therapy and Active rTMS Theta Burst Stimulation in people with Major Depressive Disorder (MDD) and Depression - Major Depressive Disorder, run by Jung-Sun Lee at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
- What is being tested?
- antidepressant therapy and Active rTMS Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prior rTMS or ECT
- Pregnancy
- Any condition deemed unsuitable by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan Medical Center
Seoul, 05530
SUNMIN KIM, MD, +821055714761, ganada47@naver.com
About this study
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
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 the 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.
- Being tested
- antidepressant therapy, Active rTMS Theta Burst Stimulation, Sham Stimulation
- Keywords
- depression, major depressive disorder, Repetitive Transcranial Magnetic Stimulation, Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidepressant therapyDrug
Participants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons.
Active rTMS Theta Burst StimulationDevice
Bilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions.
Sham StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant + Active rTMS TBS | Experimental | Not described Receives: Drug: antidepressant therapy; Device: Active rTMS Theta Burst Stimulation |
| Antidepressant + Sham then Active rTMS TBS | Sham comparator | Not described Receives: Drug: antidepressant therapy; Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptom Severity
Change in depressive symptom severity measured by the Hamilton Depression Rating Scale (HAM-D; range 0-52, higher scores indicate more severe depression)
Measured: Baseline and at 10 treatment sessions (~ 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to antidepressant monotherapy plus active rTMS TBS or antidepressant monotherapy plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jung-Sun Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Seoul National University Hospital, Nowon Eulji Medical Center, Seoul St. Mary's Hospital
- Responsible party
- Sponsor-investigator, Jung-Sun Lee, Asan Medical Center
- Investigators
- Jungsun Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529574
- Sponsor's protocol ID
- 2025-0378
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07529574
- Acronym / sponsor ID
- 2025-0378
- Keywords
- depression, major depressive disorder, Repetitive Transcranial Magnetic Stimulation, Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jung-Sun LeeUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Seoul National University Hospital, Nowon Eulji Medical Center, Seoul St. Mary's Hospital
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to antidepressant monotherapy plus active rTMS TBS or antidepressant monotherapy plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions.
| Arm | Type | Receives |
|---|---|---|
| Antidepressant + Active rTMS TBS | Experimental | Drug: antidepressant therapy, Device: Active rTMS Theta Burst Stimulation |
| Antidepressant + Sham then Active rTMS TBS | Sham comparator | Drug: antidepressant therapy, Device: Sham Stimulation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antidepressant therapyParticipants continue their baseline antidepressant regimen. Changes are restricted except for safety reasons. | Drug | Antidepressant + Active rTMS TBS, Antidepressant + Sham then Active rTMS TBS |
| Active rTMS Theta Burst StimulationBilateral sequential TBS targeting the dorsolateral prefrontal cortex (left iTBS, right cTBS), delivered over 20 sessions. | Device | Antidepressant + Active rTMS TBS |
| Sham StimulationSham 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. | Device | Antidepressant + Sham then Active rTMS TBS |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jungsun Lee, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antidepressant therapy and Active rTMS Theta Burst Stimulation in people with Major Depressive Disorder (MDD) and Depression - Major Depressive Disorder, run by Jung-Sun Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jungsun Lee, MD, PhD (+82-2-3010-3422, ljssmh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptom Severity (time frame: Baseline and at 10 treatment sessions (~ 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.