Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-27 @ 12:54 AM
Study NCT ID:
NCT00380692
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2006-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.', 'otherNumAtRisk': 48, 'otherNumAffected': 39, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.', 'otherNumAtRisk': 49, 'otherNumAffected': 32, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Early morning awakening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline Total Score (n=48, n=49)', 'categories': [{'measurements': [{'value': '40.7', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '8.43', 'groupId': 'OG001'}]}]}, {'title': '8 Week Endpoint Total Score (n=43, n=47)', 'categories': [{'measurements': [{'value': '32.3', 'spread': '10.97', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '9.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '-3.4', 'pValueComment': 'P-value for treatment group differences over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': '8 Week Improvement Score', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': '28 Week Improvement Score (n=39, n=35)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'pValueComment': 'P-value for treatment differences over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks, 28 weeks', 'description': "Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with values at timepoint.'}, {'type': 'SECONDARY', 'title': "Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Oppositional: Baseline (n=42, n=44)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Oppositional: 8 Week (n=36, n=36)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Oppositional: 28 Week (n=26, n= 25)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: Baseline (n=42, n=44)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '5.06', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: 8 Week (n=36, n=36)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '5.63', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: 28 Week (n=26, n=25)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '4.13', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive/Attention: Baseline (n=40, n=44)', 'categories': [{'measurements': [{'value': '6.8', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.68', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive/Attention: 8 Week (n=34, n=36)', 'categories': [{'measurements': [{'value': '6.1', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive/Attention: 28 Week (n=26, n=25)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'ADHD: Baseline (n=42, n=44)', 'categories': [{'measurements': [{'value': '18.5', 'spread': '9.27', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '7.49', 'groupId': 'OG001'}]}]}, {'title': 'ADHD: 8 Week (n=36, n=36)', 'categories': [{'measurements': [{'value': '15.8', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '8.69', 'groupId': 'OG001'}]}]}, {'title': 'ADHD: 28 Week (n=26, n=25)', 'categories': [{'measurements': [{'value': '13.5', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.7', 'pValueComment': 'P-value for treatment differences in Oppositional Score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '-0.3', 'pValueComment': 'P-value for treatment differences in Hyperactivity score at 8 weeks', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.3', 'pValueComment': 'P-value for treatment differences in Cognititve/Attention score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '0.3', 'pValueComment': 'P-value for treatment differences in ADHD score at 8 weeks', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'A 28-item rating scale (0 \\[not at all/never\\] to 3 \\[very much true/very often\\]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who had a value at timepoint.'}, {'type': 'SECONDARY', 'title': 'ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '10.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 weeks', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a value at timepoint.'}, {'type': 'SECONDARY', 'title': 'Sleep Measure Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Time to Fall Asleep: Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Time to Fall Asleep: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Time to Fall Asleep: 28 Week (n=35, n=35)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty Falling Asleep: Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty Falling Asleep: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty Falling Asleep: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Total Hours of Sleep: Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Total Hours of Sleep: 8 Weeks (n=42, n=46)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Total Hours of Sleep: 28 Week (n=36, n=34)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Sleep: Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '14.1', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Sleep: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '14.2', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Sleep: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '14.6', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Functional Outcome During Day:Baseline (n=48,n=49)', 'categories': [{'measurements': [{'value': '29.6', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'Functional Outcome During Day:8 Week (n=43,n=46)', 'categories': [{'measurements': [{'value': '29.1', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '4.80', 'groupId': 'OG001'}]}]}, {'title': 'Functional Outcome During Day:28Week (n=38,n=36)', 'categories': [{'measurements': [{'value': '27.8', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '4.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'pValueComment': 'P-value for treatment differences in Time to fall asleep score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.9', 'pValueComment': 'P-value for treatment differences in Difficulty falling asleep score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'pValueComment': 'P-value for treatment differences in Total hours of sleep score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.2', 'pValueComment': 'P-value for treatment differences in Quality of sleep score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '0.6', 'pValueComment': 'P-value for treatment differences in Functional outcome during day score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': '10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 \\[0-15 minutes\\] to 5 \\[\\>1 hour\\]); Total hours (numbers associated with hours of sleep).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a value at timepoint.'}, {'type': 'SECONDARY', 'title': 'Aberrant Behavior Checklist (ABC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Irritiability: Baseline (n=47, n=49)', 'categories': [{'measurements': [{'value': '17.4', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '9.49', 'groupId': 'OG001'}]}]}, {'title': 'Irritiability: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '14.5', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '9.80', 'groupId': 'OG001'}]}]}, {'title': 'Irritiability: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy: Baseline (n=47, n=49)', 'categories': [{'measurements': [{'value': '12.7', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '8.03', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '11.1', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '8.17', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy: 28 Week (n=38 , n=36)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'Stereotypic: Baseline (n=47, n=49)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.47', 'groupId': 'OG001'}]}]}, {'title': 'Stereotypic: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Stereotypic: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.77', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: Baseline (n=47, n=49)', 'categories': [{'measurements': [{'value': '28.2', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '11.56', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: 8 Week (n=43, n=45)', 'categories': [{'measurements': [{'value': '22.5', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '10.33', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '16.4', 'spread': '12.17', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '9.60', 'groupId': 'OG001'}]}]}, {'title': 'Inappropriate Speech: Baseline (n=47, n=49)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Inappropriate Speech: 8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Inappropriate Speech: 28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.452', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '1.6', 'pValueComment': 'P-value for treatment differences in Irritability score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.850', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.0', 'pValueComment': 'P-value for treatment differences in Lethargy score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.3', 'pValueComment': 'P-value for treatment differences in Stereotypic score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '-1.1', 'pValueComment': 'P-value for treatment differences in Hyperactivity score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.0', 'pValueComment': 'P-value for treatment differences in Inappropriate speech score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'The ABC is a 58-item informant-based scale comprised of five subscales (Irritability \\[15 items\\], Lethargy \\[16\\], Stereotypic Behaviors \\[7\\], Hyperactivity \\[16\\], Inappropriate Speech \\[4\\]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with values at timepoint.'}, {'type': 'SECONDARY', 'title': "Children's Social Behavior Questionnaire (CSBQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '53.6', 'spread': '14.81', 'groupId': 'OG000'}, {'value': '52.4', 'spread': '15.97', 'groupId': 'OG001'}]}]}, {'title': '8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '46.1', 'spread': '15.88', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '14.62', 'groupId': 'OG001'}]}]}, {'title': '28 Week (n=38, n=35)', 'categories': [{'measurements': [{'value': '40.4', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '17.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '0.3', 'pValueComment': 'P-value for treatment differences in Total score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with value at timepoint.'}, {'type': 'SECONDARY', 'title': 'General Health Questionnaire (GHQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline (n=48, n=49)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': '8 Week (n=43, n=46)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.31', 'groupId': 'OG001'}]}]}, {'title': '28 Week (n=38, n=36)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.9', 'pValueComment': 'P-value for treatment differences in Total score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with value at timepoint.'}, {'type': 'SECONDARY', 'title': 'Nijmeegse Ouderlijke Stress Index (NOSI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline (n=42, n=44)', 'categories': [{'measurements': [{'value': '368.6', 'spread': '79.22', 'groupId': 'OG000'}, {'value': '379.5', 'spread': '78.74', 'groupId': 'OG001'}]}]}, {'title': '8 Week (n=38, n=39)', 'categories': [{'measurements': [{'value': '350.0', 'spread': '75.07', 'groupId': 'OG000'}, {'value': '368.8', 'spread': '81.83', 'groupId': 'OG001'}]}]}, {'title': '28 Week (n=35, n=34)', 'categories': [{'measurements': [{'value': '325.2', 'spread': '85.76', 'groupId': 'OG000'}, {'value': '328.4', 'spread': '89.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-11.2', 'ciLowerLimit': '-33.3', 'ciUpperLimit': '11.0', 'pValueComment': 'P-value for treatment differences in Total score at 8 weeks.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with value at timepoint.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Irrelevant Targets Baseline (n=35, n=44)', 'categories': [{'measurements': [{'value': '12.3', 'spread': '13.95', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '16.06', 'groupId': 'OG001'}]}]}, {'title': 'Irrelevant Targets 8 Week (n=35, n=44)', 'categories': [{'measurements': [{'value': '10.0', 'spread': '16.09', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '14.36', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontargets Baseline (n=35, n=44)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '5.97', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontargets 8 Week (n=35, n=44)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '7.04', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Targets Baseline (n=35, n=44)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '9.04', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Targets 8 Week (n=35, n=44)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '14.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '5.2', 'pValueComment': 'P-value for treatment differences in Error Rate over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '3.9', 'pValueComment': 'P-value for Treatment\\*Condition Error Rate irrelevant targets over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.570', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '7.8', 'pValueComment': 'P-value for Treatment\\*Condition Error Rate relevant nontargets over time.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses "yes" when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses "no" when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.', 'unitOfMeasure': 'error rate (percentage)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Irrelevant Target Baseline (n=34, n=42)', 'categories': [{'measurements': [{'value': '1260.1', 'spread': '413.09', 'groupId': 'OG000'}, {'value': '1217.3', 'spread': '533.92', 'groupId': 'OG001'}]}]}, {'title': 'Irrelevant Target 8 Week (n=32, n=43)', 'categories': [{'measurements': [{'value': '1167.8', 'spread': '493.57', 'groupId': 'OG000'}, {'value': '1206.0', 'spread': '547.64', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontarget Baseline (n=34, n=43)', 'categories': [{'measurements': [{'value': '1208.4', 'spread': '509.62', 'groupId': 'OG000'}, {'value': '1220.9', 'spread': '550.25', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontarget 8 Week (n=33, n=43)', 'categories': [{'measurements': [{'value': '1165.4', 'spread': '570.35', 'groupId': 'OG000'}, {'value': '1168.9', 'spread': '569.16', 'groupId': 'OG001'}]}]}, {'title': 'Mean Reaction Time Hits Baseline (n=34, n=42)', 'categories': [{'measurements': [{'value': '1045.6', 'spread': '411.14', 'groupId': 'OG000'}, {'value': '1084.4', 'spread': '518.50', 'groupId': 'OG001'}]}]}, {'title': 'Mean Reaction Time Hits 8 Week (n=33, n=43)', 'categories': [{'measurements': [{'value': '1013.0', 'spread': '505.52', 'groupId': 'OG000'}, {'value': '1017.7', 'spread': '475.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-61.9', 'ciLowerLimit': '-193.5', 'ciUpperLimit': '69.8', 'pValueComment': 'P-value for Treatment differences in Reaction time over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '66.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-37.1', 'ciLowerLimit': '-160.3', 'ciUpperLimit': '86.2', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time correct rejections irrelevant target over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '62.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.904', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '-107.1', 'ciUpperLimit': '121.1', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time correct rejections relevant nontarget over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '57.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Irrelevant Target Baseline (n=33, n=39)', 'categories': [{'measurements': [{'value': '421.0', 'spread': '263.84', 'groupId': 'OG000'}, {'value': '429.4', 'spread': '382.61', 'groupId': 'OG001'}]}]}, {'title': 'Irrelevant Target 8 Week (n=29, n=41)', 'categories': [{'measurements': [{'value': '341.0', 'spread': '259.84', 'groupId': 'OG000'}, {'value': '431.7', 'spread': '363.62', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontarget Baseline (n=33, n=40)', 'categories': [{'measurements': [{'value': '442.2', 'spread': '374.99', 'groupId': 'OG000'}, {'value': '565.6', 'spread': '455.54', 'groupId': 'OG001'}]}]}, {'title': 'Relevant Nontarget 8 Week (n=30, n=41)', 'categories': [{'measurements': [{'value': '442.6', 'spread': '413.74', 'groupId': 'OG000'}, {'value': '455.6', 'spread': '376.87', 'groupId': 'OG001'}]}]}, {'title': 'Standard Deviation Hits Baseline (n=33, n=39)', 'categories': [{'measurements': [{'value': '434.3', 'spread': '302.61', 'groupId': 'OG000'}, {'value': '497.9', 'spread': '365.48', 'groupId': 'OG001'}]}]}, {'title': 'Standard Deviation Hits 8 Week (n=30, n=41)', 'categories': [{'measurements': [{'value': '381.5', 'spread': '286.96', 'groupId': 'OG000'}, {'value': '393.9', 'spread': '299.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-21.3', 'ciLowerLimit': '-152.8', 'ciUpperLimit': '110.3', 'pValueComment': 'P-value for Treatment differences in Standard Deviation of Reaction Time over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '65.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-80.9', 'ciLowerLimit': '-234.3', 'ciUpperLimit': '72.5', 'pValueComment': 'P-value for Treatment\\*Condition Standard Deviation correct rejections irrelevant target over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '77.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.840', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '-119.3', 'ciUpperLimit': '146.5', 'pValueComment': 'P-value for Treatment\\*Condition Standard Deviation correct rejections relevant nontarget over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '67.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Absent Targets Load 2 Baseline (n=33, n=35)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.61', 'groupId': 'OG001'}]}]}, {'title': 'Absent Targets Load 2 8 Week (n=34, n=35)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '6.20', 'groupId': 'OG001'}]}]}, {'title': 'Absent Targets Load 1 Baseline (n=34, n=35)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '5.49', 'groupId': 'OG001'}]}]}, {'title': 'Absent Targets Load 1 8 Week (n=34, n=35)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '13.25', 'groupId': 'OG001'}]}]}, {'title': 'Present Targets Load 1 Baseline (n=34, n=35)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '6.84', 'groupId': 'OG001'}]}]}, {'title': 'Present Targets Load 1 8 Week (34, n=35)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '10.93', 'groupId': 'OG001'}]}]}, {'title': 'Present Targets Load 2 Baseline (n=33, n=35)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '10.07', 'groupId': 'OG001'}]}]}, {'title': 'Present Targets Load 2 8 Week (n=34, n=35)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '9.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '9.9', 'pValueComment': 'P-value for Treatment differences in Error Rate over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.6', 'pValueComment': 'P-value for Treatment\\*Error Rate absent over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value for Treatment\\*Targets Load 1 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A "yes" is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a "yes" is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.', 'unitOfMeasure': 'error rate (percentage)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Load 1 Baseline (n=33, n=35)', 'categories': [{'measurements': [{'value': '1051.9', 'spread': '338.41', 'groupId': 'OG000'}, {'value': '1010.4', 'spread': '382.92', 'groupId': 'OG001'}]}]}, {'title': 'Load 1 8 Week (n=34, n=34)', 'categories': [{'measurements': [{'value': '1014.8', 'spread': '394.58', 'groupId': 'OG000'}, {'value': '928.7', 'spread': '301.04', 'groupId': 'OG001'}]}]}, {'title': 'Load 2 Baseline (n=32, n=34)', 'categories': [{'measurements': [{'value': '1411.0', 'spread': '357.50', 'groupId': 'OG000'}, {'value': '1387.2', 'spread': '595.37', 'groupId': 'OG001'}]}]}, {'title': 'Load 2 8 Week (n=34, n=34)', 'categories': [{'measurements': [{'value': '1130.4', 'spread': '460.66', 'groupId': 'OG000'}, {'value': '1294.2', 'spread': '552.25', 'groupId': 'OG001'}]}]}, {'title': 'Reaction Time Hits Load 1 Baseline (n=33, n=35)', 'categories': [{'measurements': [{'value': '932.7', 'spread': '295.14', 'groupId': 'OG000'}, {'value': '881.7', 'spread': '304.42', 'groupId': 'OG001'}]}]}, {'title': 'Reaction Time Hits Load 1 8 Week (n=34, n=34)', 'categories': [{'measurements': [{'value': '882.4', 'spread': '327.30', 'groupId': 'OG000'}, {'value': '786.8', 'spread': '257.19', 'groupId': 'OG001'}]}]}, {'title': 'Reaction Time Hits Load 2 Baseline (n=32, n=34)', 'categories': [{'measurements': [{'value': '1131.5', 'spread': '293.84', 'groupId': 'OG000'}, {'value': '1111.8', 'spread': '442.97', 'groupId': 'OG001'}]}]}, {'title': 'Reaction Time Hits Load 2 8 Week (n=34, n=34)', 'categories': [{'measurements': [{'value': '1060.0', 'spread': '343.53', 'groupId': 'OG000'}, {'value': '1110.8', 'spread': '445.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-87.2', 'ciLowerLimit': '-230.4', 'ciUpperLimit': '56.0', 'pValueComment': 'P-value for Treatment differences in Reaction Time over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '71.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '87.6', 'ciLowerLimit': '-65.6', 'ciUpperLimit': '240.8', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time correct rejections Load 1 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '77.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.239', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '70.4', 'ciLowerLimit': '-47.3', 'ciUpperLimit': '188.2', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time correct rejections Load 2 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '59.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '122.7', 'ciLowerLimit': '-35.9', 'ciUpperLimit': '281.4', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time hits Load 1 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '80.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A "yes" is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A "yes" is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct "yes" responses to targets. RT correct rejections are mean RTs of correct "no" responses when target was missing.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Load 1 Baseline (n=32, n=35)', 'categories': [{'measurements': [{'value': '406.2', 'spread': '280.59', 'groupId': 'OG000'}, {'value': '415.0', 'spread': '324.66', 'groupId': 'OG001'}]}]}, {'title': 'Load 1 8 Week (n=32, n=33)', 'categories': [{'measurements': [{'value': '408.2', 'spread': '342.39', 'groupId': 'OG000'}, {'value': '353.2', 'spread': '273.16', 'groupId': 'OG001'}]}]}, {'title': 'Load 2 Baseline (n=31, n=34)', 'categories': [{'measurements': [{'value': '515.4', 'spread': '275.40', 'groupId': 'OG000'}, {'value': '577.4', 'spread': '340.89', 'groupId': 'OG001'}]}]}, {'title': 'Load 2 8 Week (n=32, n=33)', 'categories': [{'measurements': [{'value': '544.9', 'spread': '338.26', 'groupId': 'OG000'}, {'value': '580.5', 'spread': '375.88', 'groupId': 'OG001'}]}]}, {'title': 'SD Hits Load 1 Baseline (n=32, n=34)', 'categories': [{'measurements': [{'value': '308.7', 'spread': '239.10', 'groupId': 'OG000'}, {'value': '320.3', 'spread': '263.73', 'groupId': 'OG001'}]}]}, {'title': 'SD Hits Load 1 8 Week (n=33, n=33)', 'categories': [{'measurements': [{'value': '261.6', 'spread': '231.32', 'groupId': 'OG000'}, {'value': '232.5', 'spread': '165.44', 'groupId': 'OG001'}]}]}, {'title': 'SD Hits Load 2 Baseline (n=31, n=34)', 'categories': [{'measurements': [{'value': '416.8', 'spread': '226.87', 'groupId': 'OG000'}, {'value': '424.6', 'spread': '301.20', 'groupId': 'OG001'}]}]}, {'title': 'SD Hits Load 2 8 Week (n=32, n=33)', 'categories': [{'measurements': [{'value': '380.6', 'spread': '280.36', 'groupId': 'OG000'}, {'value': '501.0', 'spread': '382.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-175.5', 'ciLowerLimit': '-351.5', 'ciUpperLimit': '0.5', 'pValueComment': 'P-value for Treatment differences in Standard Deviation of Reaction Time over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '88.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '218.1', 'ciLowerLimit': '38.0', 'ciUpperLimit': '398.2', 'pValueComment': 'P-value for Treatment\\*Condition Standard Deviation correct rejections Load 1 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '90.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '173.6', 'ciLowerLimit': '-35.7', 'ciUpperLimit': '383.0', 'pValueComment': 'P-value for Treatment\\*Condition Standard Deviation correct rejections Load 2 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '205.5', 'ciLowerLimit': '7.5', 'ciUpperLimit': '403.6', 'pValueComment': 'P-value for Treatment\\*Condition Standard Deviation hits Load 1 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '99.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline (n=30,n=33)', 'categories': [{'measurements': [{'value': '7.8', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '5.49', 'groupId': 'OG001'}]}]}, {'title': '8 Week (n=31,n=33)', 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '11.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '2.3', 'pValueComment': 'P-value for Treatment difference in Accuracy over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Baseline (n=30,n=33)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '8.24', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '7.90', 'groupId': 'OG001'}]}]}, {'title': '8 Week (n=31,n=33)', 'categories': [{'measurements': [{'value': '8.2', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '9.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value for Treatment difference in Stability of Movement over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Absent Target Baseline', 'categories': [{'measurements': [{'value': '8.0', 'spread': '16.30', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '8.49', 'groupId': 'OG001'}]}]}, {'title': 'Absent Target 8 Week', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.75', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '15.07', 'groupId': 'OG001'}]}]}, {'title': 'Present Target Baseline', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '6.14', 'groupId': 'OG001'}]}]}, {'title': 'Present Target 8 Week', 'categories': [{'measurements': [{'value': '3.7', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '5.7', 'pValueComment': 'P-value for Treatment difference in Error Rate over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '-2.2', 'pValueComment': 'P-value for Treatment\\*Condition Error Rate irrelevant targets over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.', 'unitOfMeasure': 'error rate (percentage)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and a non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Compatible Signals Baseline (n=32, n=35)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '10.06', 'groupId': 'OG001'}]}]}, {'title': 'Compatible Signals 8 Week (n=33, n=35)', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '8.92', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '11.43', 'groupId': 'OG001'}]}]}, {'title': 'Incompatible Signals Baseline (n=32, n=35)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '10.33', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '6.62', 'groupId': 'OG001'}]}]}, {'title': 'Incompatible Signals 8 Week (n=32, n=35)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '8.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '2.3', 'pValueComment': 'P-value for Treatment differences in Error Rates over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '6.3', 'pValueComment': 'P-value for Treatment\\*Condition Error Rates compatible signals over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.', 'unitOfMeasure': 'error rate (percentages)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and one non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Compatible Flankers Part 2 Baseline (n=31,n=34)', 'categories': [{'measurements': [{'value': '863.1', 'spread': '234.70', 'groupId': 'OG000'}, {'value': '925.4', 'spread': '384.55', 'groupId': 'OG001'}]}]}, {'title': 'Compatible Flankers Part 2 8 Week (n=33,n=35)', 'categories': [{'measurements': [{'value': '901.1', 'spread': '350.27', 'groupId': 'OG000'}, {'value': '897.7', 'spread': '376.63', 'groupId': 'OG001'}]}]}, {'title': 'Incompatible Flankers Part 2 Baseline (n=31,n=35)', 'categories': [{'measurements': [{'value': '959.4', 'spread': '295.32', 'groupId': 'OG000'}, {'value': '976.5', 'spread': '412.76', 'groupId': 'OG001'}]}]}, {'title': 'Incompatible Flankers Part 2 8 Week (n=33,n=35)', 'categories': [{'measurements': [{'value': '931.9', 'spread': '347.99', 'groupId': 'OG000'}, {'value': '946.2', 'spread': '419.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-22.0', 'ciLowerLimit': '-163.1', 'ciUpperLimit': '119.1', 'pValueComment': 'P-value for Treatment differences in Reaction Time over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '68.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.564', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '18.6', 'ciLowerLimit': '-47.0', 'ciUpperLimit': '84.3', 'pValueComment': 'P-value for Treatment\\*Condition Mean Reaction Time correct rejections Load 2 over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and non-missing postbaseline value at visit.'}, {'type': 'SECONDARY', 'title': 'Cytochrome P450 2D6 Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'classes': [{'title': 'Extensive Metabolizer', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Intermediate Metabolizer', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Poor Metabolizer', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': "Genotype characterization was used to determine participants' metabolic status.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}], 'periods': [{'title': 'Study Period II - Double Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Parent/Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Study Period III - Open Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One patient who completed Study Period II did not enter Study Period III.', 'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Parent/Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Study Period I was a screening and wash-out period. Study Period II (visits 2-6) was an 8-week double-blind period. Patients were randomized at Visit 2. Study Period III (visits 6-11) was a 20-week open-label extension period. Treatment groups in Study Period III refer to treatment group assignment during Double-Blind Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine', 'description': 'atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo: daily (QD), by mouth (PO) for 8 weeks.\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '2.72', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '2.90', 'groupId': 'BG001'}, {'value': '9.9', 'spread': '2.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version- Total Score', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '7.47', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '8.43', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '8.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Autism Diagnostic Interview-Revised (ADI-R)', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '12.45', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '9.68', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '11.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ADI-R is a highly structured method of eliciting information from a parent to confirm clinical impression of autism. To meet criteria for autism, child must meet criteria in each of 3 content areas (communication \\[cutoff score=8 for verbal, 7 for nonverbal\\], social interaction \\[cutoff score=10\\], restricted/repetitive behavior \\[cutoff score=3\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '3.40', 'groupId': 'BG000'}, {'value': '18.1', 'spread': '3.36', 'groupId': 'BG001'}, {'value': '18.3', 'spread': '3.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilogram/meter squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.74', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '0.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '146.0', 'spread': '16.57', 'groupId': 'BG000'}, {'value': '148.0', 'spread': '19.11', 'groupId': 'BG001'}, {'value': '147.0', 'spread': '17.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Score for Performance IQ', 'classes': [{'categories': [{'measurements': [{'value': '89.9', 'spread': '16.59', 'groupId': 'BG000'}, {'value': '94.9', 'spread': '17.46', 'groupId': 'BG001'}, {'value': '92.4', 'spread': '17.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Performance IQ was assessed with the Wechsler Intelligence Scales (WISC-III). There are 5 performal subtests consisting of nonverbal problems, all of which are timed and some of which allow bonus points for extra fast work. The mean score is 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Score for Verbal IQ', 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'spread': '18.49', 'groupId': 'BG000'}, {'value': '94.4', 'spread': '18.26', 'groupId': 'BG001'}, {'value': '93.8', 'spread': '18.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Verbal IQ was assessed with the Wechsler Intelligence Scales (WISC-III). There are 5 verbal subtests consisting of oral questions without time limits except for Arithmetic. The mean score is 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Score for the Overall Scale Intelligence', 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '16.41', 'groupId': 'BG000'}, {'value': '94.6', 'spread': '17.71', 'groupId': 'BG001'}, {'value': '92.9', 'spread': '17.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Overall scale intelligence was assessed with the Wechsler Intelligence Scales (WISC-III). The mean score is 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '14.92', 'groupId': 'BG000'}, {'value': '41.5', 'spread': '16.12', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '15.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2006-09-22', 'resultsFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2006-09-22', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-18', 'studyFirstPostDateStruct': {'date': '2006-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)', 'timeFrame': '8 weeks, 28 weeks', 'description': "Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened)."}, {'measure': "Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)", 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'A 28-item rating scale (0 \\[not at all/never\\] to 3 \\[very much true/very often\\]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.'}, {'measure': 'ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score', 'timeFrame': '28 weeks', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.'}, {'measure': 'Sleep Measure Scale', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': '10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 \\[0-15 minutes\\] to 5 \\[\\>1 hour\\]); Total hours (numbers associated with hours of sleep).'}, {'measure': 'Aberrant Behavior Checklist (ABC)', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'The ABC is a 58-item informant-based scale comprised of five subscales (Irritability \\[15 items\\], Lethargy \\[16\\], Stereotypic Behaviors \\[7\\], Hyperactivity \\[16\\], Inappropriate Speech \\[4\\]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).'}, {'measure': "Children's Social Behavior Questionnaire (CSBQ) Total Score", 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.'}, {'measure': 'General Health Questionnaire (GHQ) Total Score', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.'}, {'measure': 'Nijmeegse Ouderlijke Stress Index (NOSI) Total Score', 'timeFrame': 'Baseline, 8 weeks, 28 weeks', 'description': 'The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses "yes" when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses "no" when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A "yes" is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a "yes" is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections', 'timeFrame': 'Baseline, 8 Weeks', 'description': 'Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A "yes" is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A "yes" is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct "yes" responses to targets. RT correct rejections are mean RTs of correct "no" responses when target was missing.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy', 'timeFrame': 'Baseline, 8 weeks', 'description': 'A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement', 'timeFrame': 'Baseline, 8 weeks', 'description': 'A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.'}, {'measure': 'Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.'}, {'measure': 'Cytochrome P450 2D6 Genotype', 'timeFrame': 'baseline', 'description': "Genotype characterization was used to determine participants' metabolic status."}]}, 'conditionsModule': {'conditions': ['Autistic Disorder', 'Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '37811711', 'type': 'DERIVED', 'citation': 'Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.'}, {'pmid': '25369243', 'type': 'DERIVED', 'citation': 'Harfterkamp M, Buitelaar JK, Minderaa RB, van de Loo-Neus G, van der Gaag RJ, Hoekstra PJ. Atomoxetine in autism spectrum disorder: no effects on social functioning; some beneficial effects on stereotyped behaviors, inappropriate speech, and fear of change. J Child Adolesc Psychopharmacol. 2014 Nov;24(9):481-5. doi: 10.1089/cap.2014.0026. Epub 2014 Nov 4.'}, {'pmid': '25019647', 'type': 'DERIVED', 'citation': 'Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.'}, {'pmid': '24018545', 'type': 'DERIVED', 'citation': 'van der Meer JM, Harfterkamp M, van de Loo-Neus G, Althaus M, de Ruiter SW, Donders AR, de Sonneville LM, Buitelaar JK, Hoekstra PJ, Rommelse NN. A randomized, double-blind comparison of atomoxetine and placebo on response inhibition and interference control in children and adolescents with autism spectrum disorder and comorbid attention-deficit/hyperactivity disorder symptoms. J Clin Psychopharmacol. 2013 Dec;33(6):824-7. doi: 10.1097/JCP.0b013e31829c764f. No abstract available.'}, {'pmid': '23578015', 'type': 'DERIVED', 'citation': 'Harfterkamp M, Buitelaar JK, Minderaa RB, van de Loo-Neus G, van der Gaag RJ, Hoekstra PJ. Long-term treatment with atomoxetine for attention-deficit/hyperactivity disorder symptoms in children and adolescents with autism spectrum disorder: an open-label extension study. J Child Adolesc Psychopharmacol. 2013 Apr;23(3):194-9. doi: 10.1089/cap.2012.0012. Epub 2013 Apr 11.'}, {'pmid': '22721596', 'type': 'DERIVED', 'citation': 'Harfterkamp M, van de Loo-Neus G, Minderaa RB, van der Gaag RJ, Escobar R, Schacht A, Pamulapati S, Buitelaar JK, Hoekstra PJ. A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jul;51(7):733-41. doi: 10.1016/j.jaac.2012.04.011. Epub 2012 May 25.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (most important):\n\n* ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified \\[PDD NOS\\])\n* Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)\n* At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version\n* Intelligence quotient (IQ) score \\> 60\n\nExclusion Criteria (most important):\n\n* weight under 20 kg\n* Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder, PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia, another psychotic disorder, substance abuse;Have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; Patients who have taken (or are currently taking) anticonvulsants for seizure control.\n* patients at serious suicidal risk.\n* Contraindication to the use of atomoxetine\n* Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted."}, 'identificationModule': {'nctId': 'NCT00380692', 'briefTitle': 'Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '10483'}, 'secondaryIdInfos': [{'id': 'B4Z-UT-S017', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine', 'description': 'atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks', 'interventionNames': ['Drug: Atomoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo every day (QD), by mouth (PO) for 8 weeks\n\nThen patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['LY139603', 'Strattera'], 'armGroupLabels': ['Atomoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100 AL', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '1624 NP', 'city': 'Hoorn', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '4901 ZG', 'city': 'Oosterhout', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.645, 'lon': 4.85972}}, {'zip': '2566 ER', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}