CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- association of common CYP2D6 polymorphisms with risperidone area under the curve
研究概览
简要总结
Risperidone is an important medication used to treat children with psychiatric illnesses or neurodevelopmental disorders, such as autism. Despite excellent symptom control, the potential for side effects is worrisome. Treating these disorders is difficult because not everyone responds the same way to the same risperidone dose. One reason for this is genetic differences in how people break down the drug. Understanding these differences will help clinicians choose a dose and better predict the response so patients will be treated successfully with a lower risk for side effects. This study will research these genetic differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and clinical response in patients with psychiatric or neurodevelopmental disorders is associated with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms (SNPs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous risperidone PK study participation (CCHMC, Rainbow Babies and Children's Hospital or OSU)
- •CYP2D6 PM predicted phenotype
- •Actively taking risperidone
- •Under 18 years of age at time of enrollment
- •Signed, dated informed consent forms
排除标准
- •Investigators are unable to contact the subject/legal guardian(s)
- •Subject is no longer taking risperidone
- •CYP2D6 predicted phenotype other than PM
- •Subject is non-White, with respect to race, for PK study participation
- •Subject is 18 years of age or older
- •Subject is less than 5 years of age
- •Subject is pregnant at the time of the full PK study
- •Subject/legal guardian unwilling or unable to participate in the study
结局指标
主要结局
association of common CYP2D6 polymorphisms with risperidone area under the curve
时间窗: pre-dose (sample 1 = 0-30 minutes before first oral dose), and three at well-timed post-dose points (sample 2 = 15-30 minutes after dose; sample 3 = 60-90 minutes after dose; sample 4 = 4-6 hours after dose)
次要结局
未报告次要终点