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

Ortho-McNeil Janssen Scientific Affairs LLC0 个研究点目标入组 78 人开始时间: 2015年4月24日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•- 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: 78
•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

•- 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.

发起方