CONCERTA Lab School Study

• Status: Completed
• Trial end date: 2009-06-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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