depression
Conditions
Interventions
Test group:Jieyu Anshen Fang
control group:Jieyu Anshen Formula Simulator
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Outpatients aged 18-65, regardless of gender; 2. Conforming to the DSM-5 Diagnostic and Statistical Manual for Mental Disorders, Severe depression Obstruction diagnostic criteria; 3. Conforming to traditional Chinese medicine syndrome differentiation as liver qi stagnation type depression; 4. The HAMD-17 scores for screening/cleaning period and baseline period were 18 points = total score = 24 points,And the first item (depression) score is = 2 points; 5. The baseline HAMA total score is = 14 points, and the first item (anxiety state) is<3 points,Item 6 (depressive mood) = 2 points; 6. Understand the experimental steps and content, and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Compared with the screening/cleaning period, the total score of HAMD-17 in the baseline period has a score reduction rate of>25%; 2. Have a history of attempted suicide, or currently have a high risk of suicide, or HAMD-17 Article 3 (Suicide score) = 3 points; 3. Severe anxiety, HAMA>21 points; 4. Within 5 weeks prior to screening, those taking fluoxetine; 5. Accompanied by severe or unstable heart, liver, kidney, endocrine, digestive, blood, etc Patients with physical diseases; 6. Abnormal liver function (ALT and AST exceeding the upper limit of normal values by 2 times), abnormal renal function(BUN, Cr anomalies); 7. Clinically significant electrocardiogram abnormalities; 8. Patients with refractory depression; Individuals with a history of epilepsy, excluding those with high fever seizures during childhood; 9. According to the DSM-5 diagnostic criteria, there are alcohol and drug dependent individuals within one year; 10. Authors of depression secondary to other mental or physical illnesses; 11. Authors of depression with psychotic symptoms; 12. Unmanned or unable to take medication according to medical advice; 13. Individuals with allergies to investigational drug related components; 14. Pregnant, lactating women or those who plan to conceive in the near future; 15. The researchers believe that patients who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression-17 Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale ;Montgomery-Asberg Depression Rating Scale;Insomnia Severity Index Rating Scale;Clinical Global Impression Rating Scale;Traditional Chinese Medicine Syndrome Rating Score; | — |
Countries
China
Contacts
Public ContactChen Gang
Hubei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed