CONCERTA Lab School Study

This study has been completed.
Sponsor:
Information provided by:
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00799487
First received: November 26, 2008
Last updated: May 18, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: CONCERTA (methylphenidate HCl) or placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) [ Time Frame: Hour 4 of the Double-Blind Assessment Period Lab School Day ] [ Designated as safety issue: No ]
    PERMP (range: 0, 400) is a measure of academic productivity. 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 ] [ Designated as safety issue: No ]
    PERMP (range: 0, 400) is a measure of academic productivity. 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 correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.


Secondary Outcome Measures:
  • Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment) [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.

  • Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention) [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.

  • Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite) [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.

  • Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD.

  • Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec) [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time.

  • Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs)) [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability.

  • Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.

  • Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.

  • Hour 5.5 Test of Variables of Attention (TOVA) Commissions [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9).

  • Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).

  • Hour 8.75 Gray Silent Reading Test (GSRT) [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly.

  • Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) [ Time Frame: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118).

  • Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS) [ Time Frame: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed

  • Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).

  • Hour 5.5 Test of Variables of Attention (TOVA) Omissions [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9).

  • Hour 3.0 Grammar Task [ Time Frame: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    This task, presented once during a laboratory school day, was designed to index "attention to detail" by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Short Story With Questions for Comprehension [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Identiy Root Word [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Alphabetize List of Words [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Identify Multiple Meanings for Words [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Complete Sentences Using Words Provided [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Word Search [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

  • Hour 8.75 Packet Activity - Decode the Mystery Sentence [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ] [ Designated as safety issue: No ]
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).


Enrollment: 89
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 #1 with placebo on Day #2
Experimental: 2
CONCERTA (methylphenidate HCl) or placebo Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1
Drug: CONCERTA (methylphenidate HCl) or placebo
Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1

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

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799487

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Vice President, Medical Affairs, CNS, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00799487     History of Changes
Other Study ID Numbers: CR015118
Study First Received: November 26, 2008
Results First Received: June 25, 2010
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
ADHD
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014