临床试验/NCT00663442

NCT00663442已完成4 期

Dose Response Pharmacogenetic Study of ADHD

University of Illinois at Chicago1 个研究点分布在 1 个国家目标入组 48 人开始时间: 1999年12月最近更新: 2008年4月22日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: University of Illinois at Chicago
入组人数: 48
试验地点: 1
主要终点: ADHD RS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.

Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response

研究设计

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

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

•6-17 DSM IV criteria for ADHD Parents willing to complete measures

排除标准

•Mental retardation psychoses seizure disorder

研究组 & 干预措施

1

Experimental

OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)

干预措施: OROS methylphenidate (Drug)

结局指标

主要结局

ADHD RS

时间窗: weekly

次要结局

CGI-S(weekly)
VItal Signs(weekly)
Sleep Questionnaire(weekly)
Side Effects rating Scale(weekly)

研究者

发起方

University of Illinois at Chicago

申办方类型

Other

研究点 (1)

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