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临床试验/NCT01238822
NCT01238822已完成4 期

Response Variability in Children With ADHD

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
96
试验地点
1
主要终点
Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items

研究概览

简要总结

Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: placebo (Drug)

Low Dose Methylphenidate

Active Comparator

Low dose: 18 mg methylphenidate

干预措施: Methylphenidate (Drug)

Medium Dose Methylphenidate

Active Comparator

Medium Dosage: 36 mg if more than 50 kg and 27 mg if less than 50 kg

干预措施: Methylphenidate (Drug)

High Dose Methylphenidate

Active Comparator

54 mg if more than 50 kg and 36 mg if less than 50 kg

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items

时间窗: end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.

Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54 O - No ADHD symptoms 54 - Highest ADHD symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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