Major depressive disorder
Conditions
Interventions
Drug treatment group:Milnacipran hydrochloride tablets (Xianweining)
Sponsors
Zhongda Hospital, Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the DSM-5 diagnostic criteria for depression; 2. Age 18-65 years old (including boundary values), gender is not limited; 3. The severity of depressive symptoms was at least moderate, that is, the total score of Hamilton Depression Scale -17 (HAMD-17) was >= 17 points; 4. Patients who have not taken antidepressants, mood stabilizers, antipsychotics in the last 2 weeks, or benzodiazepines and other sedative hypnotics in the last 3 days, and who are given current Xianweining® medication according to their condition at this visit;Patients who have not taken antidepressants, mood stabilizers, antipsychotics in the last 2 weeks, or benzodiazepines and other sedative hypnotics in the last 3 days, and who are given current Xianweining® medication according to their condition at this visit; 5. The subject or his guardian signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants who are allergic or known to be allergic to Milnacipran; 2. Participants who have not responded to previous treatment with Milnacipran or have not responded to treatment with at least 2 different types of antidepressants; 3. Serious self-injury, apparent suicide attempt or behavior in the last 3 months; 4. Pregnant or lactating women, recently planned pregnancy and use of contraceptives; 5. Meet the DSM-5 diagnosis of a major mental illness other than depression; 6. Substance-related or alcohol use disorder (other than nicotine or caffeine) that meets the DSM-5 diagnostic criteria in the six months prior to screening; 7. Depression secondary to other mental or physical diseases; 8. Patients with a history of seizures (except convulsions caused by febrile convulsions in children); 9. Participants in other clinical trials within 3 months prior to screening; 10. Other severe acute or chronic diseases, mental illnesses, or abnormalities in laboratory tests that are clinically significant, as determined by the investigator, subjects are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale -17 items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychosomatic Symptom Assessment Scale;Treatment Adverse Reaction Scale; | — |
Countries
China
Contacts
Public ContactYuan Yonggui
Zhongda Hospital, Southeast University
Outcome results
None listed