Not Yet RecruitingNot Applicable

Context-Guided Personalized iTBS for Depression

China60 participantsStarted 2026-09

Plain-language summary

The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain. Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target. Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study. The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score. Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female outpatients or inpatients aged 18 to 55 years, inclusive. * Right-handed. * Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible. * A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline. * At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion. * At least primary school education and able to understand the study procedures and requirements. * Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely. * Voluntarily agrees to participate and provides written informed consent. Exclusion Criteria: * Serious or unstable medical or neurological illness. * Pregnancy or breastfeeding. * History of seizure, epilepsy, hydrocephalus, or central nervous system tumor. * Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis. * Receipt of systematic modified electroconvulsive ther…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses something called 'context-guided personalized iTBS' for depression — can you explain what that means in practice, and how it differs from standard TMS treatment I might already be able to access?
2The trial is listed as 'not yet recruiting,' so there's no timeline I can count on — given where I am in my treatment right now, does it make sense to wait for this study to open, or should we be pursuing other options first?
3The study measures treatment response using a scale called the HAMD-17 at a two-week follow-up — is two weeks long enough to know whether a treatment like this is actually working for someone in my situation?
4This trial is listed under Phase 'NA,' which I don't fully understand — what does that mean for how much is already known about the safety and effectiveness of this particular approach?
5Are there standard antidepressant treatments or already-approved TMS protocols we should try before considering an experimental study like this one, and how would you help me decide which path makes the most sense for me?'?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Response Rate at 2-Week Follow-up Based on HAMD-17

Timeframe: At 2 weeks after completion of treatment (Day 21 ± 2 days).

Trial details

NCT IDNCT07743398

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30

Contact for this trial

Zhi Yang, PhD

+86 186 1171 0840 yangz@mail.ccmu.edu.cn

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials