CONCERTA Lab School Study - Full Text View

Sponsor:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:	Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00799487

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 ADHD when compared to placebo.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: methylphenidate HCl	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy 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)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. [ Time Frame: The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. It will be administered at regular intevals throughout the 12.5 hour lab school day. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. [ Time Frame: Secondary Measures include: SKAMP, tests of inattention, reading fluency and comprehension, and memory. These will be completed during each of the laboratory assessment days (12.5 hours) ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	November 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
002: Experimental	Drug: methylphenidate HCl Optimal Subject Dose (18mg-54mg) once daily during lab school day #2
001: Experimental	Drug: methylphenidate HCl Optimal Subject Dose (18mg-54mg) once daily during lab school 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:

Males and females ages of 9 to 12 years (inclusive)
ADHD diagnosis of all subtypes (except Not Otherwise Specified)
Patients with total or subscale 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

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

No publications provided

Responsible Party:	Ortho McNeil Janssen Scientific Affairs, LLC ( Director, Clinical Development )
Study ID Numbers:	CR015118, CONCERTAATT4080
Study First Received:	November 26, 2008
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00799487 History of Changes
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:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010