Major depression disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meets the clinical diagnostic criteria for depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2.First visit to the hospital after symptom onset and either: Has not yet received antidepressant treatment or has been treated for no more than 2 weeks (acute phase), or Is receiving a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI) (maintenance phase), or Has shown inadequate response to standard antidepressant treatment (treatment-resistant depression); 3.Outpatient or inpatient; 4.Aged 18–65 years; 5.Hamilton Depression Rating Scale (HAMD-17) score > 17; 6.Provides written informed consent after fully understanding the study procedures.
Exclusion criteria
Exclusion criteria: 1.Presence of implanted metallic or electronic devices, such as cardiac pacemakers, nerve stimulators, metallic prosthetic heart valves, intraocular metallic foreign bodies, cochlear implants, metallic prostheses (e.g., artificial joints), or other ferromagnetic foreign bodies in the body; 2.History of brain disorders or other serious medical conditions; 3.Any contraindication to brain MRI (participants must complete an MRI safety screening form when providing informed consent); 4.Pregnant, breastfeeding, or planning pregnancy during the study period; 5.Acute suicidal behavior requiring emergency intervention within the past week; 6.Presence of psychotic symptoms requiring concomitant antipsychotic medication; 7.History of neuroleptic malignant syndrome or severe tardive dyskinesia; 8.Inability to adhere to prescribed medication regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (17-item version) (HAMD-17) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Scale for Suicide Ideation-Chinese Version (BSI-CV);Montgomery-Asberg Depression Rating Scale (MADRS);Resting-state fMRI metrics;Adverse effects;Hamilton Anxiety Scale (HAMA) Score; | — |
Countries
China
Contacts
Affiliated Hospital of Hangzhou Normal University