Major Depressive Disorder
Conditions
Interventions
test group:Granules of Ningkun Jieyu Decoction
Control group:Escitalopram oxalate tablets (Bishike)
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of Western medicine conforms to the diagnostic criteria for major depressive disorder in DSM-V, and the diagnostic criteria for TCM diagnosis and syndrome differentiation refer to the diagnostic basis for depression in the Traditional Chinese Medicine Industry Standard of the People's Republic of China, "Traditional Chinese Medicine Internal Medicine Disease Syndrome Diagnosis and Efficacy Criteria"; 2. Passed Hamilton Rating Scale for Depression (HAMD-17) >= 18 points; Montgomery-Asberg Depression Rating Scale (MADRS) >= 22 points; 3. Those who have not yet taken antidepressant drugs or who have taken them but have stopped taking them for 1 month; 4. Those aged between 18-65 years old, with good compliance, who can insist on taking the medicine for 2 months as prescribed by the doctor; 5. Those who voluntarily agree to participate in the study and agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. HAMD-17 scale>24 points, or HAMD-17 scale "suicide" single score>2 points; 2. Diagnosed with other serious mental illness or accompanied by other psychotic symptoms such as hallucinations and delusions; 3. Alcohol and drug abuse or drug dependence within 1 year; 4. Patients with severe or unstable heart, liver, kidney, endocrine, blood and other system diseases and clinically significant laboratory abnormalities (more than 1.5 times the upper limit of normal); 5. Those who received electroconvulsive therapy within 6 months before the interview; 6. Those who have the habit of taking probiotics or drinking yogurt; 7. Those who have participated in clinical trials of other drugs within 30 days or intend to participate in clinical trials of other drugs at the same time; 8. Those who have a history of severe drug allergy, or are allergic to the drug components involved in this study; 9. Those who are pregnant, breastfeeding or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression, HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery–Asberg Depression Rating Scale, MADRS;TCM Syndrome Evaluation Score ; | — |
Countries
China
Contacts
Public ContactLi Hao
Beijing University of Chinese Medicine
Outcome results
None listed