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临床试验/EUCTR2015-001042-28-Outside-EU/EEA
EUCTR2015-001042-28-Outside-EU/EEA进行中(未招募)不适用

Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children with ADHD (The ABC Study)

Ortho-McNeil Janssen Scientific Affairs LLC0 个研究点目标入组 89 人开始时间: 2015年4月24日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
89

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - ADHD diagnosis of all subtypes (except Not Otherwise Specified)
  • - Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores > =90th percentile relative to the general population of children by age and gender
  • - Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
  • - Ability to read and understand English
  • - Ability to attend school regularly
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 89
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Estimated Full Scale IQ score of 80 or below, Severe Learning Disability
  • - History of or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder, Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of Tourette's Syndrome
  • - Weight < 3rd percentile for age
  • - History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
  • - History of failed response to methylphenidate

研究者

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