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临床试验/NCT01130467
NCT01130467Unknown不适用

Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Chinese version of SNAP-IV Rating Scale

研究概览

简要总结

The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.

详细描述

The aims of this study are to explore the various cognitive impairments of ADHD children, to differentiate various subtypes of ADHD children, and to investigate the efficacy of anti-ADHD drugs on various cognitive performance of ADHD children by event-related potentials(ERP).

Children, aged six to 18 years old, are enrolled and assigned to three groups (normal control, pure ADHD, and ADHD with comorbidities). ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively.

Methylphenidate (either immediate-release or extended-release formulations) or atomoxetine Hydrochloride is given to ADHD participants.Continuous performance task (CPT) and ERP tasks are applied.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • health children
  • or clinical diagnosis of attention-deficit hyperactivity disorder

排除标准

  • hearing impairment
  • uncorrectable visual impairment

研究组 & 干预措施

pure ADHD

干预措施: Atomoxetine (Drug)

pure ADHD

干预措施: methylphenidate (Drug)

pure ADHD

干预措施: behavioral modification (Behavioral)

ADHD with comorbidity

干预措施: methylphenidate (Drug)

ADHD with comorbidity

干预措施: Atomoxetine (Drug)

ADHD with comorbidity

干预措施: behavioral modification (Behavioral)

结局指标

主要结局

Chinese version of SNAP-IV Rating Scale

时间窗: 8 weeks

次要结局

  • Event-related potential(8 weeks)

研究者

申办方类型
Other

研究点 (1)

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