Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Outpatients or inpatients aged 18 to 65 years (inclusive), regardless of gender; 2 Patients who meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), with either first-episode or recurrent depression, and without psychotic symptoms; 3 Patients with a total score of =17 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at both screening and baseline assessments; 4 Patients who have been taking a therapeutic dose of one selective serotonin reuptake inhibitor (SSRI) antidepressant for more than 2 weeks but show no treatment response (improvement < 50%, based on the consensus between the researcher and the patient); 5 Patients with at least 5 years of education; 6 Patients who understand and voluntarily participate in this study, can comply with the treatment process, and sign the informed consent form themselves.
Exclusion criteria
Exclusion criteria: 1 Patients with current or past diagnosis of other mental disorders that meet the criteria in DSM-5; 2 Patients with cardiac pacemakers, cochlear implants, other metallic foreign bodies or any implanted electronic devices in the body; patients with contraindications to magnetic resonance imaging (such as claustrophobia); or patients with contraindications to rTMS treatment; 3 Patients who, as recorded in the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ), have shown clinically significant poor response (improvement of depressive symptoms < 50%, based on the consensus between the researcher and the patient) to at least two antidepressants after treatment with adequate doses (specified therapeutic doses) for an adequate duration (at least 6 weeks) during the treatment process; 4 Patients with severe or unstable physical diseases involving the cardiovascular, respiratory, digestive, endocrine, urinary, hematological, nervous systems or other systems; or patients who, in the researcher’s judgment, may face potential risks to their safety or ability to fully participate in the study; 5 Women of childbearing age who are currently pregnant, lactating, or planning to become pregnant or at risk of pregnancy during the trial period; 6 Patients whose first-degree relatives (parents, children, siblings) have bipolar disorder; 7 Patients with significant suicide risk (score of = 3 on Item 3 of HAMD-17); 8 Patients who have received neuromodulation treatments such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), vagus nerve stimulation (VNS), deep brain stimulation (DBS) or light therapy within 3 months before screening; 9 Other circumstances deemed by the researcher to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale, MADRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| the 17-item Hamilton Depression Rating Scale, HAMD-17;Hamilton Anxiety Scale, HAMA;Quick Inventory of Depressive Symptomatology-Self Report, QIDS-SR;Generalized Anxiety Disorder 7-item scale, GAD-7;Visual Analogue Scale, VAS;Immediate Mood Scale, IMS;Perceived Deficits Questionnaire for Depression, PDQ-D; | — |
Countries
China
Contacts
Beijing Anding Hospital, Capital Medical University