6 Weeks Right-Amygdala TIS for Depression

Prior treatment

• Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
• Concurrent Trials : Participation in other interventional clinical studies during the trial period

Other illness

• Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status)
• Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
• Any condition deemed to compromise subject safety or study validity per clinical evaluation

Other

• Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
• Reproductive Status : Pregnancy, lactation, or plans for conception during the trial
• Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17)

• Age : 18 to 60 years (inclusive), any gender.
• Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
• Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
• Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using \>2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents\* ≥1 week prior to enrollment.
• Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
• Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent.