Depression
Conditions
Interventions
400mg daily dose group:youxinding capsules
200mg daily dose group:youxinding capsules
Placebo Group:placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) outpatients/inpatients aged 18 to 65 years, regardless of sex; (2) patients met the ICD-11 International Classification of diseases, 11th edition criteria for the diagnosis of depressive episode; (3)It conforms to the syndrome of deficiency of both heart and spleen of depression in the guide to clinical diagnosis and treatment of internal medicine of TCM, which was implemented by Chinese traditional medicine association on January 1, 2020; (4) the score of MADRS was 22-30(including boundary value) in screening period and baseline period (5) the score of CGI-S was =4 in baseline period (6) understood and volunteered to participate in this trial, sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) a history of attempted suicide within 1 year, or a high risk of suicide, or a score of =3 on the 10th item (suicidal ideation) of MADRS; (2) patients who met the ICD-11 diagnostic criteria for other mental disorders, such as schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive disorder and related disorders, somatic symptoms and related disorders, etc. (3) the rate of reduction of MADRS score at baseline was =25% , (4) patients with severe hypersensitivity to at least 2 or more drugs; (5) severe or unstable cardiovascular, liver, kidney, blood, endocrine, nervous system and other system or organ diseases, (6) present or previous history of convulsion; Or the researchers judged the presence of a disease that might increase the risk of convulsion, or that the drug or other therapy the subject is currently receiving would lower the seizure threshold; (note: not including history of febrile convulsion in childhood.)(7) patients diagnosed with hyperthyroidism or hypothyroidism within 1 year and still taking medication. (8) patients with psychotic symptoms (9) depression secondary to other mental or physical disorders;(10) inability to swallow oral drugs or suffering from diseases affecting the absorption of oral drugs (e.g. active bowel disease, partial or complete intestinal obstruction, chronic diarrhoea, etc.) ; (11) abnormal and clinically significant ECG during the screening period (eg: QTc interval =450 ms in men and =470 ms in women) ; (12) the results of laboratory examination in the screening period were abnormal and the clinical judgment of the researcher had clinical significance (such as abnormal liver function, ALT or AST was 1.5 times higher than the upper limit of the normal value; BUN was 1.5 times higher than the upper limit of the normal value; CR was 1.5 times higher than the upper limit of the normal value; PLT was below 80 × 109/L, etc.) ; (13) patients who have been taking anticoagulants (such as aspirin, Warfarin, etc.) for a long time because of physical illness. (14) patients with depression who have been or are currently treated with at least two antidepressants with different mechanisms of action in sufficient doses and full courses; (15) patients who have been systematically treated with antidepressants within 2 weeks before screening; Or withdrawal from psychotropic medication before randomization did not reach 5 half-lives (at least 2 weeks for Monoamine oxidase inhibitor and at least 30 days for fluoxetine) ; (16) having received systemic psychotherapy (interpersonal therapy, motivational therapy, cognitive behavioral therapy) within 3 months before screening, (17) those who had a history of drug abuse within 1 year before the screening;(18) a woman who is pregnant or breast-feeding or who has a positive pregnancy test result during the screening period for women of child-bearing age or who plans to become pregnant within 3 months of the start of the trial; (19) participants in other drug clinical trials within 1 month prior to screening; (20) participants were considered unfit to participate in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Montgomery-eisenberg depression scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale-17;Hamilton Anxiety Scale;Clinical global impression improvement scale; | — |
Countries
China
Contacts
Public ContactXue Wang
West China Hospital of Sichuan University
Outcome results
None listed