Context-Guided Personalized iTBS for Depression

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 therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
• Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
• Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.