Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT00530257
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'blum@email.chop.edu', 'phone': '215-590-6336', 'title': 'Dr. Nathan Blum', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OROS Methylphenidate', 'description': '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.', 'otherNumAtRisk': 31, 'otherNumAffected': 20, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.', 'otherNumAtRisk': 31, 'otherNumAffected': 5, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'decrease appetite', 'notes': 'Score of 7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stomachaches', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'prone to crying', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bites Fingernails', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tics/Nervous movements', 'notes': '7-9 on rating scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Test of Everyday Attention for Children: Walk, Don't Walk", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \\<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \\>0.655)", 'groupDescription': 'We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Gordon Diagnostic System Continuous Performance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "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."}], 'classes': [{'title': 'Omission Errors', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '31'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '42'}]}]}, {'title': 'Commission Errors', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '143'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '164'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch Walk, Don't Walk", 'groupDescription': "Same as described for TEA-Ch Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'errors', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Wechsler Intelligence Scale for Children-IV, Digit Span Subtest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "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."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This p value is not adjusted for multiple comparisons', 'groupDescription': 'We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The 30 subjects who completed both arms of the crossover analysis'}, {'type': 'SECONDARY', 'title': 'Behavior Rating Inventory of Executive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although this was included in the protocol we have not analyzed the results of this rating scale'}, {'type': 'SECONDARY', 'title': 'ADHD Rating Scale-IV, Parent and Teacher Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "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."}], 'classes': [{'title': 'Parent Inattention Rating', 'categories': [{'measurements': [{'value': '70.6', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '92.6', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Parent Hyperactivity-Impulsivity Rating', 'categories': [{'measurements': [{'value': '64.8', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Teacher Inattention Rating', 'categories': [{'measurements': [{'value': '61.1', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Teacher Hyperactivity-Impulsivity Rating', 'categories': [{'measurements': [{'value': '58.1', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'We did not correct for multiple comparisons', 'groupDescription': 'A paired t-test was used to compare the medication versus placebo.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'We used a paired t-test', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks', 'description': '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', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stimulant Side Effect Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "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."}], 'classes': [{'title': 'Insomnia', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Nightmares', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Stares/Day Dreams', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Talks less with others', 'categories': [{'measurements': [{'value': '1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Uninterested in others', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Irritable', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Stomachaches', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Headaches', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Sad', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Prone to Crying', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Bites fingernails', 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Euphoric', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-03'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children-Sky Search Dual Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '429'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '101'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch: Walk, Don't Walk.", 'groupDescription': "Same as described for TEA-Ch: Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children: Score Dual Task (DT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '19'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The p value adjusts for multiple comparisons', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children: Creature Counting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '12.8'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '28.2'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch: Walk, Don't Walk", 'groupDescription': "Same as described for TEA-Ch: Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children: Map Mission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '57'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '52'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch: Walk, Don't Walk", 'groupDescription': "Same as described for TEA-Ch: Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children: Sky Search', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '25.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '26'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch: Walk, Don't Walk", 'groupDescription': "Same as described for TEA-Ch: Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}, {'type': 'PRIMARY', 'title': 'Test of Everyday Attention for Children: Opposite Worlds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication', 'description': "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."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '66'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Same as described for TEA-Ch: Walk, Don't Walk", 'groupDescription': "Same as described for TEA-Ch: Walk, Don't Walk", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': '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..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OROS Methylphenidate', 'description': "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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OROS Methylphenidate', 'description': "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."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2007-09-13', 'resultsFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-15', 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stimulant Side Effect Rating Scale', 'timeFrame': '2 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': "Test of Everyday Attention for Children: Walk, Don't Walk", 'timeFrame': '2 weeks', 'description': "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."}, {'measure': 'Gordon Diagnostic System Continuous Performance Test', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Wechsler Intelligence Scale for Children-IV, Digit Span Subtest', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children-Sky Search Dual Task', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children: Score Dual Task (DT)', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children: Creature Counting', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children: Map Mission', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children: Sky Search', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Test of Everyday Attention for Children: Opposite Worlds', 'timeFrame': '2 weeks', 'description': '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..'}], 'secondaryOutcomes': [{'measure': 'Behavior Rating Inventory of Executive Function', 'timeFrame': '2 Weeks'}, {'measure': 'ADHD Rating Scale-IV, Parent and Teacher Version', 'timeFrame': '2 Weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder', 'Methylphenidate', 'Attention', 'Working Memory'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type\n* Parent and Teacher Ratings \\>85 percentile on inattention and/or hyperactivity/impulsivity scales\n* Estimated Intelligence Quotient (IQ) \\> 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test\n\nExclusion Criteria:\n\n* 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\n* Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation\n* Use within 14-days of a monoamine oxidase inhibitor\n* History of side effects on any methylphenidate preparation that required stopping the medication\n* Inability to swallow a capsule or tablet\n* Chronic treatment with coumarin, clonidine, or tricyclic antidepressants'}, 'identificationModule': {'nctId': 'NCT00530257', 'acronym': 'CHOP', 'briefTitle': 'Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '2004-3-3588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OROS-methylphenidate', 'description': '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.', 'interventionNames': ['Drug: OROS-methylphenidate']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (sugar pill)', 'armGroupLabels': ['Placebo']}, {'name': 'OROS-methylphenidate', 'type': 'DRUG', 'otherNames': ['Concerta', 'Osmotic-Release Oral System -methylphenidate'], 'description': '18 mg to 54 mg once a day for 1 week', 'armGroupLabels': ['OROS-methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nathan J Blum, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ortho-McNeil Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}