Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-02 @ 6:49 PM
Study NCT ID:
NCT00530335
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2007-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks', 'otherNumAtRisk': 45, 'otherNumAffected': 45, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Middle insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 8 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.'}, {'type': 'SECONDARY', 'title': "Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Total ADHD Symptoms Score', 'categories': [{'measurements': [{'value': '-15.0', 'spread': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive Subscale', 'categories': [{'measurements': [{'value': '-9.9', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity/Impulsive Subscale', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'ADHD Index Subscale', 'categories': [{'measurements': [{'value': '-9.3', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': "Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Total ADHD Symptoms Score', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive Subscale', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive/Impulsive Subscale', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'ADHD Index Subscale', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '6.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', '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', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.749', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.886', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Physical Component Summary Baseline', 'categories': [{'measurements': [{'value': '47.9', 'spread': '9.52', 'groupId': 'OG000'}]}]}, {'title': 'Physical Component Summary Change from Baseline', 'categories': [{'measurements': [{'value': '1.20', 'spread': '9.64', 'groupId': 'OG000'}]}]}, {'title': 'Mental Component Summary Baseline', 'categories': [{'measurements': [{'value': '44.46', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Mental Component Summary Change from Baseline', 'categories': [{'measurements': [{'value': '0.86', 'spread': '6.61', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning Baseline', 'categories': [{'measurements': [{'value': '54.74', 'spread': '5.42', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning Change from Baseline', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '4.94', 'groupId': 'OG000'}]}]}, {'title': 'Role-Physical Baseline', 'categories': [{'measurements': [{'value': '44.04', 'spread': '13.16', 'groupId': 'OG000'}]}]}, {'title': 'Role-Physical Change from Baseline', 'categories': [{'measurements': [{'value': '2.20', 'spread': '13.37', 'groupId': 'OG000'}]}]}, {'title': 'Bodily Pain Baseline', 'categories': [{'measurements': [{'value': '49.55', 'spread': '11.43', 'groupId': 'OG000'}]}]}, {'title': 'Bodily Pain Change from Baseline', 'categories': [{'measurements': [{'value': '0.78', 'spread': '10.28', 'groupId': 'OG000'}]}]}, {'title': 'General Health Perception Baseline', 'categories': [{'measurements': [{'value': '48.30', 'spread': '10.12', 'groupId': 'OG000'}]}]}, {'title': 'General Health Perception Change from Baseline', 'categories': [{'measurements': [{'value': '0.91', 'spread': '7.21', 'groupId': 'OG000'}]}]}, {'title': 'Vitality Baseline', 'categories': [{'measurements': [{'value': '43.41', 'spread': '10.22', 'groupId': 'OG000'}]}]}, {'title': 'Vitality Change from Baseline', 'categories': [{'measurements': [{'value': '1.23', 'spread': '8.73', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning Baseline', 'categories': [{'measurements': [{'value': '43.21', 'spread': '14.31', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning Change from Baseline', 'categories': [{'measurements': [{'value': '1.17', 'spread': '13.54', 'groupId': 'OG000'}]}]}, {'title': 'Role-Emotional Baseline', 'categories': [{'measurements': [{'value': '39.09', 'spread': '14.16', 'groupId': 'OG000'}]}]}, {'title': 'Role-Emotional Change from Baseline', 'categories': [{'measurements': [{'value': '2.64', 'spread': '13.54', 'groupId': 'OG000'}]}]}, {'title': 'Mental Health Baseline', 'categories': [{'measurements': [{'value': '43.18', 'spread': '10.45', 'groupId': 'OG000'}]}]}, {'title': 'Mental Health Change from Baseline', 'categories': [{'measurements': [{'value': '1.80', 'spread': '7.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.\n\nCalculate: norm-based score=Z-score\\*10+50 in each subscale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Change From Endpoint to Baseline in Stroop Color Word Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Word Test Baseline', 'categories': [{'measurements': [{'value': '91.3', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Word Test Change from Baseline', 'categories': [{'measurements': [{'value': '4.1', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'Color Test Baseline', 'categories': [{'measurements': [{'value': '72.8', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Color Test Change from Baseline', 'categories': [{'measurements': [{'value': '4.9', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Color-Word Test Baseline', 'categories': [{'measurements': [{'value': '51.7', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'Color-Word Test Change from Baseline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.', 'unitOfMeasure': 'number of correct answers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'High Pulse(bpm)=Increase ≥15 to a value >120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low Pulse(bpm)=Decrease ≥15 to a value <50', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'High SBP(mmHg)=Increase ≥20 to value at least 180', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low SBP(mmHg)=Decrease ≥20 to value of at most 90', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High DBP(mmHg)=Increase ≥15 to value at least 105', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low DBP(mmHg)=Decrease ≥15 to value of at most 50', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 8 weeks', 'description': 'Vital signs reported are Pulse (beats per minute \\[bpm\\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Weight Loss=Any Decrease of at Least 7%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Weight Gain=Any Increase of at Least 7%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 8 weeks', 'description': 'Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'QTcF Interval of >450 milliseconds (ms)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF Interval of >480 milliseconds', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF Interval of >500 milliseconds', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF Interval increase from baseline of ≥30 msec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'QTcF Interval increase from baseline of ≥60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 8 weeks', 'description': 'The Fridericia correction of the QT interval(QTcF) was used.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Cytochrome P450 2D6 (CYP2D6) Phenotype Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'classes': [{'title': 'Extensive Metabolizer', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Poor Metabolizer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine', 'description': '40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.12', 'spread': '8.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Measures severity of the patient's overall severity of attention-deficit/hyperactivity disorder (ADHD) symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-Inv:SV-J ADHD Index Subscale", 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. ADHD Index Subscale consisted of 12 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 36.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-Inv:SV-J Hyperactive/Impulsive Subscale", 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '6.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. Hyperactive/Impulsive Subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-Inv:SV-J Inattentive Subscale", 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '3.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. Inattention subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-Inv:SV-J Total Symptoms Score", 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version-Japanese . Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-S:SV-J ADHD Index Subscale", 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. ADHD Index Subscale consisted of 12 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 36.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-S:SV-J Hyperactive/Impulsive Subscale", 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Hyperactive/Impulsive Subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-S:SV-J Inattentive Subscale", 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Inattention subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Conners' Adult ADHD Rating Scale-S:SV-J Total Symptoms Score", 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Anxiety Rating Scale-14 Items Total Score', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Depression Rating Scale-17 Items Total Score', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2007-09-14', 'resultsFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-22', 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events Leading to Discontinuation', 'timeFrame': 'over 8 weeks'}], 'secondaryOutcomes': [{'measure': "Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)", 'timeFrame': 'baseline and 8 weeks', 'description': 'Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.'}, {'measure': "Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)", 'timeFrame': 'baseline and 8 weeks', 'description': 'Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.'}, {'measure': 'Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity', 'timeFrame': 'baseline and 8 weeks', '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)."}, {'measure': 'Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score', 'timeFrame': 'baseline and 8 weeks', 'description': 'The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).'}, {'measure': 'Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score', 'timeFrame': 'baseline and 8 weeks', 'description': 'The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).'}, {'measure': 'Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores', 'timeFrame': 'baseline and 8 weeks', 'description': 'Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.\n\nCalculate: norm-based score=Z-score\\*10+50 in each subscale.'}, {'measure': 'Change From Endpoint to Baseline in Stroop Color Word Test', 'timeFrame': 'baseline and 8 weeks', 'description': 'An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study', 'timeFrame': 'over 8 weeks', 'description': 'Vital signs reported are Pulse (beats per minute \\[bpm\\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).'}, {'measure': 'Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study', 'timeFrame': 'over 8 weeks', 'description': 'Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.'}, {'measure': 'Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion', 'timeFrame': 'over 8 weeks', 'description': 'The Fridericia correction of the QT interval(QTcF) was used.'}, {'measure': 'Cytochrome P450 2D6 (CYP2D6) Phenotype Status', 'timeFrame': '8 weeks', 'description': 'CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '21265936', 'type': 'RESULT', 'citation': 'Takahashi M, Takita Y, Goto T, Ichikawa H, Saito K, Matsumoto H, Tanaka Y. An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder. Psychiatry Clin Neurosci. 2011 Feb;65(1):55-63. doi: 10.1111/j.1440-1819.2010.02159.x.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* at least 18 years of age\n* meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood\n* have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater\n\nExclusion Criteria:\n\n* Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.\n* Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.\n* Patients who have any history of bipolar disorder (DSM-IV), any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.\n* Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder."}, 'identificationModule': {'nctId': 'NCT00530335', 'briefTitle': 'Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '11821'}, 'secondaryIdInfos': [{'id': 'B4Z-JE-LYED', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine', 'interventionNames': ['Drug: Atomoxetine']}], 'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['LY139603', 'Strattera'], 'description': '40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks', 'armGroupLabels': ['Atomoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Aichi', 'country': 'Japan', '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': 32.51879, 'lon': 130.62158}}, {'zip': '272-8516', 'city': 'Chiba', 'country': 'Japan', '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': 35.6, 'lon': 140.11667}}, {'zip': '960-1295', 'city': 'Fukushima', 'country': 'Japan', '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': 37.75, 'lon': 140.46667}}, {'zip': '060-8648', 'city': 'Hokkaido', 'country': 'Japan', '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.'}, {'zip': '661-0002', 'city': 'Hyōgo', 'country': 'Japan', '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': 43.36667, 'lon': 144.43333}}, {'zip': '920-8641', 'city': 'Ishikawa', 'country': 'Japan', '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': 26.42333, 'lon': 127.82139}}, {'zip': '259-1193', 'city': 'Kanagawa', 'country': 'Japan', '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': 37.58333, 'lon': 139.91667}}, {'zip': '862-0920', 'city': 'Kumamoto', 'country': 'Japan', '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': 32.80589, 'lon': 130.69181}}, {'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', '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': 35.02107, 'lon': 135.75385}}, {'zip': '634-8522', 'city': 'Nara', 'country': 'Japan', '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': 34.68505, 'lon': 135.80485}}, {'zip': '350-0495', 'city': 'Saitama', 'country': 'Japan', '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': 35.90807, 'lon': 139.65657}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', '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': 35.6895, 'lon': 139.69171}}], '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'}}}}