Major Depressive Disorder
Conditions
Interventions
rTMS-Tiny treatment group:rTMS-Tiny stimulator with iTBS mode targeting left DLPFC. Days 1-2: 10 sessions/day
Days 3-7: 2 sessions/day
Days 8-9: 10 sessions/day. 1800 pulses/session, 50-min intervals, 50 sessions total, 90000 pulses.
SNT treatment group:rTMS-Tiny stimulator with iTBS mode targeting left DLPFC. Days 1-5: 10 sessions/day, 1800 pulses/session, 50-min intervals, 50 sessions total, 90000 pulses.
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years, any gender, with primary school education or above; 2. Meeting DSM-5 diagnostic criteria for Major Depressive Disorder, currently in moderate to severe depressive episode (HAMD-17>=18); 3. Stable antidepressant medication regimen for at least 4 weeks prior to treatment, or medication-free, maintained throughout the study period (including follow-up); 4. Right-handed; 5. Able to undergo structural MRI and resting-state functional MRI (fMRI) examination.
Exclusion criteria
Exclusion criteria: 1. Any psychiatric diagnosis other than MDD (e.g., autism spectrum disorder, severe cognitive impairment, epilepsy, mania, psychosis); 2. Structural neurological lesions that increase seizure risk or affect brain connectivity (e.g., brain tumor, history of stroke); 3. Major somatic diseases, including cardiovascular, respiratory, hepatic, renal diseases, or malignant tumors; 4. Contraindications to TMS or MRI (e.g., metal implants, pacemaker, history of epilepsy); 5. Received electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within the past three months; 6. History of psychiatric neurosurgery for depression (e.g., deep brain stimulation); 7. Pregnant or breastfeeding women; 8. Plans to adjust medication regimen during the study period; 9. Severe suicidal ideation or behavior (HAMD-17 item 3 score of 3 or 4); 10. Current use of lorazepam >2 mg/day (or an equivalent dose of other benzodiazepines), or any antiepileptic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) score;Hamilton Anxiety Rating Scale (HAMA) score;Insomnia Severity Index (ISI) score;Cognitive function assessed by the THINC-integrated tool (THINC-it);Beck Depression Inventory Second Edition (BDI-II) score;Childhood Trauma Questionnaire-Short Form (CTQ-SF) score;Mini-International Neuropsychiatric Interview (MINI);7-item Generalized Anxiety Disorder Scale (GAD-7) score;16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) score;Young Mania Rating Scale (YMRS) score ;Brief Symptom Inventory-18 (BSI-18) score;Pittsburgh Sleep Quality Index (PSQI) score; | — |
Countries
China
Contacts
Public ContactJiahui Deng
Peking University Sixth Hospital
Outcome results
None listed