None listed
Conditions
Interventions
Drug : SOCG tablets (700mg once) and placebo, manufactured by Korea New Drug Co., Ltd., are orally administered three times a day, 3T each time for 8 weeks.
Sponsors
Dunsan Korean Medicine Hospital of Daejeon University
Chungnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19 to 64 2. Those diagnosed with major depressive disorder in DSM-V(Diagnostic and Statistical Manual of Mental Disorders-5) 3. Those with a K-HDRS(Korean Version of the Hamilton Depression Rating Scale) score of 22 or higher 4. Those who voluntarily decide to participate and sign the agreement.
Exclusion criteria
Exclusion criteria: 1. Who is at risk of suicide 2. Patients with major depressive disorder who need hospitalization treatment 3. Persons with psychotic features such as delusions, hallucinations, or history 4. Those with a history of manic, schizophrenic, and mixed artworks 5. People with alcohol or other substance abuse / dependence or history 6. Patients who are taking medicines 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., except when the person taking the drug has passed 4 weeks from the last dose of the drug at the screening time) 7. Those who are taking medicines (furosemide, thiazide, amphotericin, cisplatin, etc.) that can show or cause hypokalemia and those that may show hypokalemia (hypomagnesemia, Bartter syndrome, Gitelman syndrome, a disease that can cause high aldosteronemia, etc.) 8. Those taking Warfarin 9. Who has been diagnosed with arrhythmia 10. People with a medical condition that may affect the degree of depression (eg. myocardial infarction, brain tumor, multiple sclerosis, pancreatic disease, hypo/hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatoid arthritis, Cancer, cerebrovascular disease, dementia, epilepsy, etc.) 11. People with chronic illnesses that are not well controlled for proper treatment (chronic active hepatitis, hypertension, diabetes, etc.) * Uncontrolled hypertension is defined as a state in which blood pressure is not controlled below 140/90 mmHg despite the administration of three or more antihypertensive agents with a combination of appropriate drugs including diuretics in sufficient doses. And uncontrolled diabetes is defined as a state that maintain HbA1c = 9.0%, despite adequate dosing. 12. Those who are being treated for liver cancer, liver cirrhosis, chronic kidney failure, or who are being treated with congestive heart failure classified as NYHA Class III-IV 13. Patients with liver dysfunction or renal impairment (ALT, AST, ALP = twice the normal upper limit or creatinine > 2.0 mg / dL at screening) 14. Persons with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 15. Anyone who has a disease that may affect the absorption of the drug or who has a digestive disorder after surgery related that 16. Those who participated in other clinical trials within one month before starting the study 17. People with hypersensitivity reactions and allergies to research-related drugs 18. Those who are taking herbal medicine other than this clinical trial 19. Persons who are unable to understand the consent form due to mental retardation or intellectual problems 20. Pregnant or lactating women 21. Those who are unlikely to be pregnant and who do not agree to the approved methods of contraception (double contraception*, intrauterine contraceptive, and spermicide) during the trial *Double contraception refers to the use of other contraceptive methods (such as infertility surgery, intrauterine contraception, cream, jelly or foam for contraception) in conjunction with condom contraception (condoms, diaphragm, etc.). 22. If the investigator determines that the subject is not suitable for the clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Change in total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Percentage of subjects whose overall score improved by more than 50%;Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Percentage of subjects who improved to less than 7 points;The Korean version of the Beck Depression Inventory-? (K-BDI-?);Korean version of Symptom Checklist-95-Revision (KSCL-95);Insomnia Severity Index (ISI);State-Trait Anxiety Inventory-Korean version (STAI-K);Pattern Identifications Tool for Depression (PITD);Melatonin & Cortisol Study;EuroQol-5 dimension (EQ-5D);STAXI-K | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Kyung Seo
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed