KCT0002763招募中未知
A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-Groups, Dose Finding Exploratory Study to Evaluate Safety and Efficacy of SOCG Tablet in Depressive Disorder
Dunsan Korean Medicine Hospital of Daejeon University0 个研究点目标入组 148 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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