NCT00799487

CONCERTA Lab School Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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 CONCERTA (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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	CONCERTA (methylphenidate HCl) or placebo	Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2
DRUG	CONCERTA (methylphenidate HCl) or placebo	Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1

Timeline

• Start date: 2009-01-02
• Primary completion: 2009-06-26
• Completion: 2009-06-26
• First posted: 2008-12-01
• Last updated: 2020-03-12
• Results posted: 2010-10-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study