NCT03233867已完成不适用
A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity
Aevi Genomic Medicine, LLC, a Cerecor company1 个研究点 分布在 1 个国家目标入组 2,503 人开始时间: 2017年8月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,503
- 试验地点
- 1
- 主要终点
- Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity
研究概览
简要总结
This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.
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
- •Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped.
- •Subject is 6 to 17 years of age (inclusive) at the time of informed consent.
- •Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.
- •Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.
排除标准
- •Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems.
- •Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.
- •Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.
结局指标
主要结局
Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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