CONCERTA Lab School Study

NCT00799487 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: CR015118NCT007994872015-001042-28
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)

  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 of the Double-Blind Assessment Period Lab School Day

• Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)

  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.

  Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Secondary Outcomes (23)

• 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 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 (Msec)

  Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

CONCERTA (methylphenidate HCl) or placebo DRUG

Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2

1

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Study Sites (3)

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Related Links

• Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children with ADHD

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: VP Medical Affairs, CNS
• Organization: Ortho-McNeil Janssen Scientific Affairs, LLC

609-730-2136

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: January 2, 2009
• Primary Completion: June 26, 2009
• Study Completion: June 26, 2009
• Last Updated: March 12, 2020
• Results First Posted: October 1, 2010

Record last verified: 2020-02

Locations

US (3)