depression
Conditions
Interventions
Experimental group:Jieyu Anshen Fang
control group:Jieyu Anshen Fang Simulator
Sponsors
Hubei Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Outpatient patients aged 60 years or older with clear consciousness normal comprehension and language expression abilities; 2. Meets the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5); 3. According to traditional Chinese medicine syndrome differentiation it is depression of liver qi stagnation type; 4. HAMD-17 scores in the screening/cleansing period and baseline period are between 18 points and a total score of 24 points and the first item (depressive mood) score is = 2 points; 5. The baseline HAMA total score is = 14 points and the first item (anxious mood) is<3 points and the sixth item (depressed mood) is = 2 points; 6. Understand the experimental steps and content and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The total score of HAMD-17 in the baseline period decreased by more than 25% compared to the screening/cleaning period; 2. Have a history of attempted suicide or currently have a high risk of suicide or have a HAMD-17 score of = 3 on the third criterion (suicide score); 3. Severe anxiety HAMA score>21; 4. Individuals who have taken fluoxetine within the past 5 weeks prior to screening; 5. Patients with severe or unstable physical diseases such as heart liver kidney endocrine digestive and hematological disorders; Patients with combined organic brain diseases or malignant tumors; 6. Abnormal liver function (ALT and AST exceeding the upper limit of normal values by 2 times) abnormal kidney function (BUN and Cr abnormalities); 7. Clinically significant electrocardiogram abnormalities; 8. Patients with refractory depression; Individuals with a history of epilepsy except for febrile seizures in childhood; 9. According to the DSM-5 diagnostic criteria individuals with alcohol and drug dependence within one year; 10. Individuals with depression secondary to other mental or physical illnesses; 11. The author of depression accompanied by psychotic symptoms; 12. Individuals with communication barriers or those who are unable to take medication according to medical advice; 13. Individuals allergic to research drug related ingredients; 14. Pregnant lactating or recently planned pregnancies; 15. The researchers believe that patients who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17 rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA rating;ISI rating;Traditional Chinese Medicine Syndrome Scoring;CGI score (disease severity);MADRS score; | — |
Countries
China
Contacts
Public ContactChen Gang
Hubei Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed