Amygdala-Targeted Transcranial Temporal Interference Stimulation for Major Depressive Disorder: A Randomized Sham-Controlled Trial of Clinical Efficacy and Neurobiological Mechanisms

Prior treatment

• Receipt of electroconvulsive therapy (ECT) or other physical treatments, such as transcranial magnetic stimulation (TMS), within the 30 days before enrollment.

Other illness

• A history of other psychiatric disorders, neurological disorders, or substance abuse that, in the investigator's judgment, may interfere with the assessment of treatment efficacy.
• A history of epilepsy, seizures, or convulsive episodes.
• Presence of intracranial metallic foreign bodies or metallic implants in or near the heart.
• Presence of organic brain disease, or a history of severe head injury or cranial surgery.
• An unstable psychiatric condition or significant suicide risk, as assessed by the investigator.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Other

• Women who are pregnant or breastfeeding.
• Current participation in another interventional clinical trial.

• Aged 18 to 55 years, inclusive, with no restriction on sex.
• Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as determined by a study physician.
• A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥17 at screening/baseline.
• The antidepressant medication regimen must remain stable from at least 30 days before signing the informed consent form through the study period.
• In the judgment of the investigator, the participant or their legally authorized representative is able to understand the purpose and procedures of the study, comply with the study protocol, and provide written informed consent.