Depression
Conditions
Interventions
Sponsors
Peking University Sixth Hospital, Peking University Institute of Mental Health
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Meet the diagnostic criteria for major depressive disorder (MDD) of the Fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with single or repeated episodes; 3. Stable medication for 4 weeks or more before randomization; 4. HAMD-17 score >=17 points before randomization; 5. Clinical Global Impression Scale (CGI-S) severity score >=4 points (i.e., moderate or above); 6. Subjects participate voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Combined with other mental disorders, such as schizophrenia, bipolar disorder, schizoaffective disorder, obsessive-compulsive disorder, secondary depression, etc. 2. Severe suicidal tendencies in the current episode, etc. [those with a history of suicide or items 2-5 of the ‘’suicide idea’’ subscale in the Columbia Suicide Severity Rating Scale (C-SSRS) are positive and have suicidal ideation] . 3. Combined with serious heart, liver and kidney function diseases, and abnormal thyroid function, the researchers judged that they are not suitable for enrollment. 4. Combined with organic brain disease (such as ischemic, hemorrhagic stroke, brain tumor, etc.) or severe brain trauma; or history of organic brain disease or trauma with neurological sequelae; previous use of vagus nerve stimulators or other intracranial implants. 5. Contraindications for combined TMS treatment or magnetic resonance examination, such as those who cannot tolerate magnetic stimulation; those with skin ulcers at the treatment site; patients with tinnitus; claustrophobia. 6. Combined history of epilepsy (at least 2 unprovoked seizures with an interval of more than 24 hours, or diagnosed with epilepsy syndrome, or seizures in the past 12 months). 7. Patients with metal implants (including device leads) on or near the head, such as cochlear implants, implanted deep brain stimulators, auditory brainstem implants, vagus nerve stimulators, aneurysm clips, or stand. 8. There are cardiac pacemakers, artificial cardiopulmonary apparatus and other devices that may be subject to electromagnetic interference in the body. Those with metal stents or metal objects (including titanium) in the blood vessels in the body. 9. Patients with high fever (body temperature >= 39.1°C). 10. Patients who have used transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT) or light therapy in the past 3 months. 11. Those who have participated in clinical trials of other drugs or medical devices within 30 days. 12. Pregnant or breastfeeding patients, or those who plan to become pregnant during the test period. 13. Low cognitive level or communication difficulties, unable to cooperate with examination, treatment or evaluation. 14. Alcohol (or drug) dependence or abuse in the past year. 15. Critically ill patients. 16. Other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale-17 items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions-Improvement (CGI-I) Scale;Montgomery-Asberg Depression Rating Scale;Performance Evaluation Form for Test Devices;Clinical Global Impression-Severity (CGI-S) Scale;Columbia Suicide Severity Rating Scale (C-SSRS);Safety Evaluation Form for Test Devices;Vital Signs; | — |
Countries
China
Contacts
Public ContactYue Weihua
Peking University Sixth Hospital, Peking University Institute of Mental Health
Outcome results
None listed