Depression
Conditions
Interventions
Group 1:youxinding capsules
Group 2: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, including cut-off values, regardless of sex; 2. In accordance with the ICD-11, single or recurrent depressive episode diagnostic criteria; 3. It conforms to the syndrome of deficiency of both heart and spleen in the guide to clinical diagnosis and treatment of internal medicine of TCM, depression implemented by the Chinese Academy of Traditional Chinese medicine from January to January 2020, and conforms to the diagnostic standard of syndrome differentiation in the 4.1.2 diagnostic standard of TCM in the scheme 4. Montgomery Asperger's Rating Scale for depression (MADRS) at screening and baseline: =22 and < 30; 5. Total Hama Hamilton Anxiety Rating Scale score =17 at screening and baseline. 6. Clinical global impression scale-severity of illness (CGI-S) score =4 at baseline; 7. Understand and volunteer to participate in the trial, signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. General Information: (1) pregnant or lactating women; (2) subjects of reproductive age who are unable to guarantee or refuse to use medically approved contraceptive methods within 28 days from the screening period to the last dose of the drug (except for the incapacity of the subject or the partner) ; (3) history of psychoactive substance abuse, such as drug (opioid) abuse, alcohol abuse, drug abuse; (4) the results of laboratory examination and 12-lead ECG in screening period were as follows: the results of laboratory examination in screening period were abnormal, which were clinically significant: abnormal liver and renal function (AST and ALT levels were 1.5 times higher than the upper limit of normal value; UREA levels were 1.5 times higher than the upper limit of normal value; SCR levels were 1.5 times higher than the upper limit of normal value) ; The 12-lead ECG indicates clinically significant abnormalities that may affect the safety of the subject, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmias, or significant QTc prolongation (QTC > 450ms in men and QTC > 470ms in women) . 2. Any of the following medical histories or co-morbidities: (1) allergic constitution (e.g. , to two or more drugs, food allergy) or known allergy to any of the ingredients in urapidil; (2) at present or in the past, they met the ICD-11 diagnostic criteria for other mental disorders, such as schizophrenia and other psychotic disorders, bipolar disorder, anxiety disorder, separation disorder, eating disorder, etc. (3) depressive symptoms related to organic mental disorders caused by systemic somatic diseases or some neurological disorders, such as hypothyroidism, stroke, and depression caused by guillain-barre syndrome; (4) researchers with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease disease, and neurology diseases were not considered suitable for inclusion; (5) history of refractory depression. In the past, patients with two or more antidepressants with different pharmacological mechanisms were still ineffective after sufficient dose and full course of treatment(6) received other non-drug treatment within 3 months before screening, it includes ECT or MECT, RTMS, systemic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavior therapy, etc.) , Cam, acupuncture, VNS, DBS, phototherapy or other physiotherapy related to mental diseases; (7) had a history of attempted suicide within 1 year, or was currently at high risk of suicide, or had a Montgomery-asperger depression scale -MADRS-RRB-DRS) score oItem on item 10(suicidal ideation) ; (8) Montgomery Asperger's Rating Scale for depression (MADRS-RRB- score at baseline was reduced by =25% compared with the screening period, (9) inability to swallow oral medication, or have severe gastrointestinal disorders (e.g. active or recurrent peptic ulcer, chronic diarrhea) that the investigator has assessed may affect drug absorption, or had received prior treatment that might affect drug absorption (eg, gastrointestinal surgery) ; (10) poorly controlled grade 2 or more hypertension [ systolic blood pressure (SBP)=160 mm Hg and/or diastolic blood pressure (DBP)=100 mm Hg at rest detected ] ; (11) subjects who had undergone major surgery within the 3 months before screening or who were scheduled for major surgery during the study period and were considered unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Montgomery-eisenberg depression scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;Clinical global impression improvement scale;TCM syndrome score;Arizona sexual experience scale; | — |
Countries
China
Contacts
Public ContactLei Chen\Xue Wang
West China Hospital of Sichuan University
Outcome results
None listed