Clinical trial NCT00799487: CONCERTA Lab School Study
Official title: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children With ADHD (The ABC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Attention Deficit Hyperactivity Disorder
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 89
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
timeFrame: Hour 4 of the Double-Blind Assessment Period Lab School Day
measure: Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)
timeFrame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period
Secondary outcomes:
measure: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)
timeFrame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)
timeFrame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)
timeFrame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Test of Variables of Attention (TOVA) Commissions
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Gray Silent Reading Test (GSRT)
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)
timeFrame: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
timeFrame: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 5.5 Test of Variables of Attention (TOVA) Omissions
timeFrame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 3.0 Grammar Task
timeFrame: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Short Story With Questions for Comprehension
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Identiy Root Word
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Alphabetize List of Words
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Identify Multiple Meanings for Words
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Complete Sentences Using Words Provided
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Word Search
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
measure: Hour 8.75 Packet Activity - Decode the Mystery Sentence
timeFrame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Las Vegas
country: United States
state: Nevada
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: