Major Depressive Disorder
Conditions
Interventions
The experimental group:Yushuda Tablet
Control group:Yushuda Tablet Simulator
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients or inpatients aged 18 to 65, male or female; 2. Meet the diagnostic criteria for severe depressive episodes in the Diagnostic and Statistical Manual for Mental Disorders (5th Edition) (DSM-5); 3. Comply with the dialectical standards of dampness, turbidity, spleen stagnation, and qi stagnation in traditional Chinese medicine; 4. The total score of HAMD17 during the screening and baseline periods is>=17 points and=2 points; 6. The CGI-S score during the screening and baseline periods is>=3 points; 7. Understand and voluntarily participate in this experiment, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with DSM-5 schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, physical symptoms and related disorders, and other mental disorders; 2. Have a history of attempted suicide in the past one year; Or there is currently a high risk of suicide; The Hamilton Depression Scale -17 (HAMD17), item 3 (suicide) score during the screening or baseline period is>=3 points; 3. Depression attack secondary to organic mental disorder caused by certain systemic disease or certain nervous system disease, such as depression caused by hypothyroidism; 4. Compared with the screening period, the total score of HAMD17 in the baseline period has a score reduction rate of>=25%; 5. Patients with severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, neurological or other system diseases; 6. There have been seizures in current or past medical history; Or researchers determine the presence of diseases that may increase the risk of seizures; The medication or other treatment currently being received by the subject may lower the threshold for seizures; Excluding a single episode of high fever convulsion in childhood; 7. Those who are known to be allergic to patchouli, tangerine peel, cardamom, herbaceous cardamom, and atractylodes macrocephala (stir fried with bran), or to at least two drugs; 8. Screening for individuals who have been dependent on substances such as alcohol (excluding nicotine) within the first 6 months; 9. Do not swallow oral drugs, or have a history of gastric and intestinal surgery or any other conditions that may interfere with the absorption, distribution, metabolism or excretion of absorption; 10. Abnormalities that the investigator believes have obvious clinical significance in physical examination and laboratory examination of the subject during screening or baseline period; The following indicators exceed the following standards: ALT or AST laboratory test values are 2 times higher than the upper limit of normal values; Cr is higher than the upper limit of normal value; Among the 5 indicators of thyroid function, 2 or more indicators are 1.2 times higher than the upper limit of normal value or 0.8 times lower than the lower limit of normal value, or researchers believe that there is hypothyroidism or hyperthyroidism; 11. Abnormal electrocardiogram (ECG) during the screening period with significant clinical significance, such as QTc interval>=450ms for males and>=470ms for females, which the researchers consider unsuitable for inclusion; 12. Those who have experienced past or current episodes and have been treated with two sufficient doses of antidepressants for at least 4 weeks (such as following the maximum dose specified in the instructions) but are not effective in their treatment; 13. Systematically received antidepressant treatment within 2 weeks before screening, and stopped using psychotropic drugs before randomization for less than 5 half lives (monoamine oxidase inhibitor for at least 2 weeks, fluoxetine for at least 1 month); 14. Within the first 3 months of screening, patients who have received systematic modified electroconvulsive therapy (MECT) or transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or systematic psychological therapy; Those who have received systematic phototherapy, laser therapy, acupuncture and moxibustion and other traditional Chinese medicine treatment and sy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of HAMD17 total score compared to baseline after 8 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective rate of HAMD17 after 8 weeks of treatment. (Effective means that the reduction rate of HAMD17 total score compare with the baseline is = 50%).;The effective rate of MADRS after 8 weeks of treatment. (Effective means that the reduction rate of MADRS total score compare with the baseline is = 50%).;The effective rate of Chinese medicine dampness trapped spleen, qi stagnation syndrome symptom score after 8 weeks of treatment.(Effective means that the reduction rate of Chinese medicine dampness trapped spleen, qi stagnation syndrome symptom score total score compare with the baseline is = 50%).; | — |
Countries
China
Contacts
Public ContactHuafang Li
Shanghai Mental Health Center
Outcome results
None listed