major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? aged from 18 to 65 (including 18 and 65) years old, males or females;? meeting with the diagnostic criteria for depression in the American Manual of Mental Disorders Diagnosis and Statistics Fifth Edition (DSM-5) or the International Classification of Diseases ICD-10 diagnostic criteria, both for first episode and relapse;? meeting with the diagnostic criteria for liver depression and kidney deficiency syndrome in traditional Chinese medicine;? the Hamilton Depression Scale (HAMD-17) scores >17 during the screening and baseline periods;? primary school education or above, and able to understand the research content;? participated voluntarily in this study and signed an informed consent form?
Exclusion criteria
Exclusion criteria: ? current or previous diagnosis of other major mental disorders other than major depressive disorders according to DSM-5 or ICD-10, such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychiatric disorders, bipolar disorder, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, alcohol (or drug) dependence or abuse, personality disorders, etc;? a depressive episode of organic mental disorder secondary to a systemic or neurological disease, such as a depressive episode caused by hypothyroidism;? the researcher believes that it is not suitable to participate in this study due to severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, blood system, or other system diseases;? women with positive blood chorionic gonadotropin (HCG)/urine HCG test results, pregnancy or lactation; Or men or women of reproductive age who had reproductive potential during the study were unable to take effective contraceptive measures; Or plan to become pregnant within 3 months after the beginning of the study;? meeting with other TCM syndrome types, especially the syndrome of yin deficiency of liver and kidne, the syndrome of hyperactivity of heart and liver fire, etc;? the researcher believes that it is not suitable to participate in this study for other reasons?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of HAMD score compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in score reduction rates of HAMA?CGI?QIDS-SR16?PSQI?PSP-CHN and PHQ-15 at different times; | — |
Countries
China
Contacts
Beijing Anding Hospital,Capital Medical University