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

• ClinicalTrials.gov Identifier: NCT00530257
• Recruitment Status: Completed
• First Posted: September 17, 2007
• Results First Posted: December 19, 2011
• Last Update Posted: December 19, 2011
• Sponsor: Children's Hospital of Philadelphia
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Placebo; Drug: OROS-methylphenidate	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder
• Study Start Date: June 2004
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: June 2008

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; 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; Placebo (sugar pill)
Active Comparator: OROS-methylphenidate; 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; 18 mg to 54 mg once a day for 1 week; Other Names: Concerta; Osmotic-Release Oral System -methylphenidate

Outcome Measures

Primary Outcome Measures :

1. Test of Everyday Attention for Children: Walk, Don't Walk [ Time Frame: 2 weeks ]
   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. Gordon Diagnostic System Continuous Performance Test [ Time Frame: 2 weeks ]
   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.
3. Wechsler Intelligence Scale for Children-IV, Digit Span Subtest [ Time Frame: 2 weeks ]
   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.
4. Test of Everyday Attention for Children-Sky Search Dual Task [ Time Frame: 2 weeks ]
   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.
5. Test of Everyday Attention for Children: Score Dual Task (DT) [ Time Frame: 2 weeks ]
   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.
6. Test of Everyday Attention for Children: Creature Counting [ Time Frame: 2 weeks ]
   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.
7. Test of Everyday Attention for Children: Map Mission [ Time Frame: 2 weeks ]
   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.
8. Test of Everyday Attention for Children: Sky Search [ Time Frame: 2 weeks ]
   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.
9. Test of Everyday Attention for Children: Opposite Worlds [ Time Frame: 2 weeks ]
   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..

Secondary Outcome Measures :

1. Behavior Rating Inventory of Executive Function [ Time Frame: 2 Weeks ]
2. ADHD Rating Scale-IV, Parent and Teacher Version [ Time Frame: 2 Weeks ]
   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

Other Outcome Measures:

1. Stimulant Side Effect Rating Scale [ Time Frame: 2 weeks ]
   Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

• Principal Investigator: Nathan J Blum, M.D.; Children's Hospital of Philadelphia

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT00530257
• Other Study ID Numbers: 2004-3-3588
• First Posted: September 17, 2007
• Results First Posted: December 19, 2011
• Last Update Posted: December 19, 2011
• Last Verified: November 2011

Keywords provided by Children's Hospital of Philadelphia:

Attention Deficit Hyperactivity Disorder; Methylphenidate; Attention; Working Memory

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; 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