KCT0003052招募中未知
A clinical trial to investigate the factors affecting adverse drug reactions and clinical efficacy of clozapine in Korean
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •?Patients who can provide their written informed consents according to GCP and related regulations
- •?Men and women over the age of 19
- •?Patients who are diagnosed as schizophrenia spectrum disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and expected to use clozapine for more than 57 days(More than 14 days after the last dose of clozapine in patients who previously used clozapine)
- •?Patients who understand the contents of the clinical research explanations and have given written informed consents
排除标准
- •? Patients who took a drug that the investigator deemed inappropriate before clozapine administration within 2 weeks before screening. (which may be acceptable if the investigator considers to have no effect on pharmacokinetics or safety of the study drug)
- •? Patients who are planning a pregnancy or who can not use approved methods for contraception during the study period
- •? Patients who are considered to be inappropriate for study participation by the investigator based on other reasons including clinical laboratory test results
研究者
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