NCT02811211已完成不适用
A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Aevi Genomic Medicine, LLC, a Cerecor company1 个研究点 分布在 1 个国家目标入组 1,894 人开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,894
- 试验地点
- 1
- 主要终点
- Presence of mGluR network mutations
研究概览
简要总结
This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.
详细描述
Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female ≥6 and ≤17 years of age.
- •The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
- •The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).
排除标准
- •The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.
结局指标
主要结局
Presence of mGluR network mutations
时间窗: At study enrollment
次要结局
未报告次要终点
研究者
研究点 (1)
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