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Trial record 1 of 1 for:    NCT00799409
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Lab School Day Study for CONCERTA of Older Children With ADHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00799409
First received: November 26, 2008
Last updated: April 24, 2014
Last verified: April 2014
  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: Placebo/ CONCERTA (methylphenidate HCl) Drug: CONCERTA (methylphenidate HCl) / Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

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 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 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 ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's 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 ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's 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 ]
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's 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 Composite Cutoff Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure 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. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).

  • Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure 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. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

  • Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure 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. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

  • 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 ]
    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 ]
    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 Standard Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure 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. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

  • 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 ]
    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) Reading Quotient [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]
    Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.

  • Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score [ Time Frame: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in 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). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.

  • 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 ]
    The DIBELS (range: 0, 376), 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. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within 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 ]
    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 Standard Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure 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. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

  • Hour 3.0 Grammar Task [ Time Frame: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period ]
    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 ]
    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 Root Word [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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: 78
Study Start Date: December 2008
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) / Placebo Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2
Drug: 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
Experimental: 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
Drug: 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

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.
  Eligibility

Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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: NCT00799409

Locations
United States, California
Irvine, California, United States
United States, Texas
Houston, Texas, United States
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00799409     History of Changes
Other Study ID Numbers: CR015046
Study First Received: November 26, 2008
Results First Received: June 14, 2010
Last Updated: April 24, 2014

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
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 27, 2017