A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Glucose and lipid metabolism abnormality
研究概览
简要总结
The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment
详细描述
- The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
- On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
- •Patients who are 19 years or older
- •Patient who understands the contents of the clinical research and provide their written informed consent forms
排除标准
- •Patients taking a drug that the researcher deems inappropriate before clozapine administration
- •Patients who can not use an appropriate contraceptive method during the study period
- •Patients whom the researcher deemed inappropriate for clinical research participation
结局指标
主要结局
Glucose and lipid metabolism abnormality
时间窗: Change from baseline glucose and lipid profiles on Day 15, and 57
Change from baseline glucose and lipid profiles after clozapine administration
Sleeping tendency assessment
时间窗: Change from baseline sleeping tendency assessment on Day 15, and 57
Epworth sleepiness scale (ESS). * ESS is comprised of eight questions, each asking about the subject's likelihood of dozing off or falling asleep in a particular situation that is commonly met in daily life. * Each ESS item score measures a particular "situational sleep propensity", and respondents use a four-point scale from 0 (no chance of dozing/falling asleep) to 3 (high chance of dozing/falling asleep) for each of the eight questions. * The sum of eight item scores (the total ESS score) measures the subject's average sleep propensity across those different situations in daily life. A total ESS score of 16-24 points indicates severe excessive daytime sleepiness.
Liver function abnormality
时间窗: Change from baseline liver function test on Day 15, and 57
Change from baseline liver function test
次要结局
- Cognitive function assessment(Change from baseline MCCB on Day 57, and 127)
- Clinical symptom assessment(Change from baseline BPRS on Day 15, and 57)
研究者
Euitae Kim
Professor
Seoul National University Bundang Hospital