Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. male or female patients aged 18-60 (inclusive) who meet the diagnostic criteria of DSM-5 major depressive disorder (MDD) have definite panic attacks in the past two months, outpatients or inpatients; 2. the subjects signed a written informed consent (ICF), indicating that they understood the purpose and process of the test and is willing to participate in the study; 3) Hamilton Depression Scale (HAMD-17) total score >=18 and < 24.
Exclusion criteria
Exclusion criteria: 1. patients who participated in other clinical trials within 30 days before screening; 2. patients who had taken antidepressants, antipsychotics, emotional stabilizers and sedative hypnotics within 30 days before screening; 3. patients diagnosed as alcohol or drug abuse and dependence according to DSM-5 within 3 months before screening (nicotine and caffeine dependence are not excluded). Regular drinking and drinking before going to bed; 4. patients with serious suicide risk in the past 6 months (HAMD-17 suicide factor >=3 points); 5. patients who have received electroconvulsive therapy (ECT) in the past 3 months; 6. pregnant and lactating women who are unable to take appropriate contraceptive measures during the trial; 7. it is known that there is a history of allergy or comorbidity (previous history of allergic reactions such as drug-induced allergic reactions, rashes, urticaria, etc.); 8. patients with tardive dyskinesia or malignant syndrome; 9. have a history of drug resistance (it was defined as taking two different antidepressants during the treatment period, system treatment is defined as the maximum tolerable dose treatment for 6 weeks); 10. patients with a history of epilepsy or have a history of hypothalamus or hypophysis; 11. patients with previous history of brain organic diseases or complications, such as Parkinson's disease; 12. consciousness disorder caused by any reason in the past 12 months; 13. patients with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease and other physical diseases or medical history; 14. have a history of malignant tumor or complications; 15. the results of biochemical examination, hematology examination or urinalysis are not within the normal range of the laboratory, and the researcher thinks it has clinical significance; 16. refractory depression; 17. this study does not include language barriers and illiteracy. If the researchers determine that patients do not have informed consent ability, they needed their legal guardian to sign the ICF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD reduce;fMRI;plasma metabolites;PDSS reduce;PASS reduce; | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG;HAMA reduce;MADRS reduce;CGI; | — |
Countries
China
Contacts
Peking University Sixth Hospital