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
Overview
- Phase
- Phase 4
- Intervention
- CONCERTA (methylphenidate HCl) / Placebo
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Enrollment
- 78
- Primary Endpoint
- Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 one of the two 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.
Investigators
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.
Arms & Interventions
1
CONCERTA (methylphenidate HCl) / Placebo Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2
Intervention: CONCERTA (methylphenidate HCl) / Placebo
2
Placebo/ CONCERTA (methylphenidate HCl) Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2
Intervention: Placebo/ CONCERTA (methylphenidate HCl)
Outcomes
Primary Outcomes
Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
Time Frame: Hour 4 of the of the Lab School Day during Double-Blind Assessment Period
PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)
Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)
Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period
PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.
Secondary Outcomes
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)(Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)(Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)(Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score(Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)(Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score(Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 3.0 Grammar Task(Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Short Story With Questions for Comprehension(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Identify Root Word(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Alphabetize List of Words(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Identify Multiple Meanings for Words(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Complete Sentences Using Words Provided(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Word Search(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)
- Hour 8.75 Packet Activity Decode the Mystery Sentence(Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period)