None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Women aged 20 to 65 years 2) Those diagnosed with Diagnostic and Statistical Manual of Mental Disorders-Fifth edition major depression 3) Those with a Korean Hamilton Depression Rating Scale score of 14 or higher 4) who has voluntarily participated and signed the agreement
Exclusion criteria
Exclusion criteria: 1) Those who are at risk of suicide 2) Persons with psychotic features such as delusions, hallucinations, or history 3) A man with a history of manic, schizophrenic, and mixed artworks 4) Alcohol or other substances Abuse / Dependence or history 5) Those who have had acute and chronic infectious diseases for the last 2 weeks 6) Patients who are taking drugs or substances that may affect the degree of depression (eg anxiolytics, antidepressants, antipsychotics, corticosteroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram , Isoniazid, yohimbine, etc.) 7) People with a medical condition that may affect the degree of depression (eg, myocardial infarction, brain tumor, multiple sclerosis, hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatoid arthritis, Vascular disease, epilepsy, etc.) 8) Those with chronic diseases that are not well controlled by appropriate treatment (chronic active hepatitis, hypertension, diabetes, etc.) 9) Those who are treated with liver cancer or liver cirrhosis, chronic kidney failure, congestive heart failure, etc. 10) Creatinine clearance calculated by the cockcroft-Gault formula for renal patients is less than 50 ml / min 11) Those who have a disease that may affect the absorption of the drug or who have digestive disturbance after the related surgery 12) Those who participated in other clinical trials with interventions within one month before the start of the study 13) People who have hypersensitivity to research-related drugs and allergy history 14) Those who are unable to understand the consent form due to mental retardation or intellectual problems 15) Pregnant or lactating women 16) Those who do not consent to the approved method of contraception during the clinical trial (double condom *, oral or parenteral hormone contraceptive, intrauterine contraceptive, and spermicide) * Double contraception refers to the use of other contraceptive methods (such as infertility surgery, intrauterine contraceptive, oral contraceptive, other hormonal delivery system, pessary cream, jelly or foam) in conjunction with condom contraception (condoms, diaphragm, etc.). 17) If the subject is found to be inappropriate for participation in clinical trials due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Korean Hamilton Depression Rating Scale(K-HDRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The Korean version of the Beck Depression Inventory(BDI-K);Instrument on Pattern Identification for Depression;Beck Hopelessness Scale;Korean Symptom Checklist-95 (KSCL-95);Insomnia Severity Index (ISI);State-Trait Anxiety Inventory;EuroQol-5 dimension (EQ-5D);visual analogue scale;Emotional Stimulus Test;Brain-derived neurotrophic factor (BDNF);Inflammatory cytokines and tumor necrosis factor (IL-1ß, IL-2, IL-4, IL-6, IL-10, TNF-a, IFN-?, TGF-ß1);Depression-related genetic polymorphism & Epigenetic test (SLC6A4, SLC6A3, SLC1A1, GAD1, NR2A, NRG1, TPH2, GRM7, OXTR, AVPR1A, MGLUR5, COMT, BDNF, IL6, IL1beta);microbiome;Adverse reaction;Epigenetic test (SLC6A4, BDNF, OXTR) | — |
Countries
Korea, Republic of
Contacts
Dunsan Korean Medicine Hospital of Daejeon University