Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory

NCT00530257 | Completed Phase 4 Results

• 1 other identifier: 2004-3-3588
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Methylphenidate; Attention; Working Memory

Outcome Measures

Primary Outcomes (9)

• Test of Everyday Attention for Children: Walk, Don't Walk

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don't Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.

  2 weeks

• Gordon Diagnostic System Continuous Performance Test

  This is a measure of sustained attention \& response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a "1" is followed by a "9". There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.

  2 weeks

• Wechsler Intelligence Scale for Children-IV, Digit Span Subtest

  The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.

  2 weeks

• Test of Everyday Attention for Children-Sky Search Dual Task

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.

  2 weeks

• Test of Everyday Attention for Children: Score Dual Task (DT)

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.

  2 weeks

• Test of Everyday Attention for Children: Creature Counting

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.

  2 weeks

• Test of Everyday Attention for Children: Map Mission

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.

  2 weeks

• Test of Everyday Attention for Children: Sky Search

  The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.

  2 weeks

• Test of Everyday Attention for Children: Opposite Worlds

  The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..

  2 weeks

Secondary Outcomes (2)

• Behavior Rating Inventory of Executive Function

  2 Weeks

• ADHD Rating Scale-IV, Parent and Teacher Version

  2 Weeks

Other Outcomes (1)

• Stimulant Side Effect Rating Scale

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (sugar pill);Subjects will be equally randomized and will receive one week of treatment with placebo and compared to subjects who were randomized to receive one week of OROS-methylphenidate.

Drug: Placebo

OROS-methylphenidate

ACTIVE COMPARATOR

Subjects will be equally randomized and will receive one week of treatment with the optimal dose of OROS methylphenidate compared with subjects randomized to receive one week of placebo.

Drug: OROS-methylphenidate

Interventions

Placebo DRUG

Placebo (sugar pill)

Placebo

OROS-methylphenidate DRUG

18 mg to 54 mg once a day for 1 week

Also known as: Concerta, Osmotic-Release Oral System -methylphenidate

OROS-methylphenidate

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
• Parent and Teacher Ratings \>85 percentile on inattention and/or hyperactivity/impulsivity scales
• Estimated Intelligence Quotient (IQ) \> 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test

You may not qualify if:

• Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
• Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
• Use within 14-days of a monoamine oxidase inhibitor
• History of side effects on any methylphenidate preparation that required stopping the medication
• Inability to swallow a capsule or tablet
• Chronic treatment with coumarin, clonidine, or tricyclic antidepressants

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

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: Dr. Nathan Blum
• Organization: The Children's Hospital of Philadelphia

blum@email.chop.edu

215-590-6336

Study Officials

• Nathan J Blum, M.D.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: June 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 19, 2011
• Results First Posted: December 19, 2011

Record last verified: 2011-11

Locations

US (1)