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

Attention Deficit Hyperactivity Disorder Clinical Trial

— CHOP  

Official title:

Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530257
• Other study ID #: 2004-3-3588
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2007
• Last updated: November 15, 2011
• Start date: June 2004
• Est. completion date: June 2008

Study information

• Verified date: November 2011
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Placebo
Placebo (sugar pill)
• OROS-methylphenidate
18 mg to 54 mg once a day for 1 week

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Behavior Rating Inventory of Executive Function		2 Weeks	No
Secondary	ADHD Rating Scale-IV, Parent and Teacher Version	This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity	2 Weeks	No