Major Depressive Disorder
Conditions
Interventions
Test Group:MECT Treatment and rTMS Treatment
Control Group:MECT Treatment
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (inclusive); 2. Right-handed, of Han ethnicity, with at least 6 years of formal education; 3. Meeting the diagnostic criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as confirmed by a psychiatrist; 4. A total score of >= 17 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 5. Meeting the relevant clinical indications for modified electroconvulsive therapy (MECT) in the treatment of MDD, with the subject meeting at least one of the following conditions: complicated with severe suicidal tendency, prominent feelings of guilt and self-blame, marked psychotic symptoms, catatonic syndrome, refusal of food and water; or being diagnosed with treatment-resistant MDD (with poor therapeutic response after standardized antidepressant pharmacotherapy); or having intolerance to antidepressant treatment; 6. Subjects and/or their legal guardians being able to comprehend the study content and sign a written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. A diagnosis of any other psychiatric disorders meeting the diagnostic criteria of the DSM-5; 2. With a history of or current comorbidity of cerebral organic diseases such as epilepsy, craniocerebral trauma, intracranial infection, cerebrovascular diseases, intracranial space-occupying lesions or neurodegenerative diseases (e.g., dementia, Parkinson's disease); 3. Having contraindications to MECT or rTMS, such as the presence of metallic implants in the intracranial or cervical region (e.g., aneurysm clips, cochlear implants, deep brain stimulators); 4. Comorbid with severe somatic diseases involving the cardiovascular, respiratory, hepatic, renal, hematologic, endocrine or immune systems, and deemed ineligible for MECT/rTMS treatment by the investigator; 5. Female subjects who are pregnant or lactating; 6. Severe cognitive impairment or inability to cooperate with follow-up and assessment procedures; 7. Having received MECT or rTMS treatment within 6 months prior to enrollment; 8. Abnormal findings in laboratory tests (hematology, biochemistry) or electrocardiogram (ECG), and deemed ineligible for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in total HAMD scores between the two groups after treatment;Changes in total neurocognitive function assessment scores between the two groups before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction rate of total HAMD scores after treatment;Proportion of patients with a 25% to 49% reduction in total HAMD scores after treatment;Reduction of HAMD scores to <= 7 points; | — |
Countries
China
Contacts
Public ContactFengchun Wu
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed