KCT0007571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 BTS granule in Major Depressive Disorder
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 126
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 65(Year)（—）
- 性别
- All
入选标准
- •1. Men and women aged 19 to 65
- •2. Participant diagnosed with major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5)
- •3. Participant with a K-HDRS(Korean Version of the Hamilton Depression Rating Scale) score of 18 or higher
- •4. Participant with a BMI (Body Mass Index) of 18.5 or higher
- •5. Participant who voluntarily decide to participate and sign the agreement
排除标准
- •1. Participant with a risk of suicide
- •2. Participant with major depressive disorder who need hospitalization treatment
- •3. Participant who received electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, or transcranial magnetic stimulation (TMS) within three months
- •4. Participant who are diagnosed and being treated as a panic disorder, obsessive disorder, post-traumatic stress disorder, or personality disorder
- •5. Participant with a history of manic, schizophrenic, or mixed episode
- •6. Participant with a current or lifetime alcohol or other substance abuse/dependence
- •7. Participant 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) within 4 weeks
- •8. Participant who have experienced defecations more than 3 times a day within 7 days and loose stool, or who are taking other laxatives
- •9. Participant with symptoms of abdominal pain, vomiting, or loss of appetite due to digestive disorders
- •10. Participant 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. Participant with chronic illnesses that are not well controlled with proper treatment (chronic active hepatitis, hypertension, diabetes, etc.)
- •12. Participant 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. Participant with liver dysfunction or renal impairment (ALT, AST, ALP = twice the normal upper limit or creatinine > 2.0 mg/dL at screening)
- •14. Participant with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •15. Participant who has a disease that may affect the absorption of the drug or who has a digestive disorder after surgery
- •16. Participant who participated in the other clinical trials within 3 month
- •17. Participant with hypersensitivity reactions and allergies to investigational product
- •18. Participant who are taking other herbal medicines
- •19. Participant who are unable to understand the consent form due to mental retardation or intellectual problems
- •20. Pregnant or lactating women
- •21. Participant who are likely to be pregnant and who do not agree to the approved methods of contraception (double contraception, intrauterine contraceptive, and spermicide) during the trial
- •22. Participant who are determined to be unsuitable by the investigator
研究者
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