The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT00530257
This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).
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Notify Me6 year–12 year
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo (sugar pill)
18 mg to 54 mg once a day for 1 week
Other names: Concerta, Osmotic-Release Oral System -methylphenidate
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.
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.
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.
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.
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.
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.
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.
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.
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..
Time frame: 2 Weeks
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
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.
Children's Hospital of Philadelphia
Other
Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder
Acronym: CHOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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