CONCERTA Lab School Study

• Conditions: Attention Deficit Hyperactivity Disorder; MedDRA version: 18.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001042-28-Outside-EU/EEA
• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-24
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 89

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
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): - Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)<br>- Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) ;Timepoint(s) of evaluation of this end point: At the Hour stated above of the of the Lab School Day during Double-Blind Assessment Period