Lab School Study for CONCERTA®

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: methylphenidate HCl (Drug); methylphenidate HCl (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

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 ADHD when compared to placebo.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study

Primary outcome: The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score.

Secondary outcome: Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory.

Detailed description: The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral and cognitive effects of CONCERTA® (methylphenidate HCl) on older children with ADHD This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2 laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of methylphenidate HCl. The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12. 5 hours). Participants will be assessed for adverse events throughout the study.

Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.

Minimum age: 9 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females ages 9 to 12 years (inclusive)

- ADHD diagnosis of all subtypes (except Not Otherwise Specified)

- Patients with total or subscale 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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Irvine, California 92612, United States; Recruiting

Houston, Texas 77007, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: November 2008
Ending date: July 2009
Last updated: January 30, 2009