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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (sugar pill) |
| |
| OROS-methylphenidate |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior Rating Inventory of Executive Function | 2 Weeks | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulant Side Effect Rating Scale | 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. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan J Blum, M.D. | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Parents of 41 patients inquired about participating in the study. Four did not meet eligibility requirements leaving 37 eligible children. Three families elected not to participate leaving 34 children. Three children did not complete the dose finding stage leaving 31 children who entered the double blind placebo controlled crossover study.
Participants were recruited from an outpatient ADHD evaluation and treatment program at a pediatric academic medical center. Eligible children wer: 1) Age 6-12 years and at least in 1st grade; 2) DSM-IVTR diagnosis of ADHD, Combined Type;3) Parent and teacher ratings on the ADHD Rating Scale-IV > 85th percentile; 5) IQ greater than 75
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| ID | Title | Description |
|---|---|---|
| FG000 | OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed on the measures described below. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed on the measures described below. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| decrease appetite | Gastrointestinal disorders | Systematic Assessment | Score of 7-9 on rating scale |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Blum | The Children's Hospital of Philadelphia | 215-590-6336 | blum@email.chop.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
18 mg to 54 mg once a day for 1 week |
|
|
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 |
| 2 Weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases |
|
|
|
| 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. | 31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available | Posted | Median | Full Range | errors | 2 weeks |
|
|
|
|
| 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. | The 30 subjects who completed both arms of the crossover analysis | Posted | Median | Full Range | units on a scale | 2 weeks |
|
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|
|
| Secondary | Behavior Rating Inventory of Executive Function | Although this was included in the protocol we have not analyzed the results of this rating scale | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
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| 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 | We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo | Posted | Mean | Standard Deviation | Percentile | 2 Weeks |
|
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|
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| Other Pre-specified | Stimulant Side Effect Rating Scale | 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. | Posted | Mar 2011 | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
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| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
|
|
|
| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
|
|
|
| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
|
|
|
| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
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|
|
| 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. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
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|
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| 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.. | Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed | Posted | Median | Full Range | units on a scale | 2 weeks |
|
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|
|
| 0 |
| 31 |
| 20 |
| 31 |
| EG001 | Placebo | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects. | 0 | 31 | 5 | 31 |
|
| Irritable | Nervous system disorders | Systematic Assessment | 7-9 on rating scale |
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| stomachaches | Nervous system disorders | Systematic Assessment | 7-9 on rating scale |
|
| Headaches | Nervous system disorders | Systematic Assessment | 7-9 on rating scale |
|
| prone to crying | Nervous system disorders | Systematic Assessment | 7-9 on rating scale |
|
| Bites Fingernails | Psychiatric disorders | Systematic Assessment | 7-9 on rating scale |
|
| Tics/Nervous movements | Nervous system disorders | Systematic Assessment | 7-9 on rating scale |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Teacher Inattention Rating |
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| Teacher Hyperactivity-Impulsivity Rating |
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| Stares/Day Dreams |
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| Talks less with others |
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| Uninterested in others |
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| Decreased appetite |
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| Irritable |
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| Stomachaches |
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| Headaches |
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| Drowsiness |
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| Sad |
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| Prone to Crying |
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| Anxiety |
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| Bites fingernails |
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| Euphoric |
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| Dizziness |
|