Viewing Study NCT01010750

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Ignite Creation Date: 2025-12-24 @ 4:52 PM
Ignite Modification Date: 2026-04-18 @ 6:22 PM
Study NCT ID: NCT01010750
Status: COMPLETED
Last Update Posted: 2021-06-14
First Post: 2009-11-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'LDX 50 mg', 'otherNumAtRisk': 18, 'otherNumAffected': 12, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MAS-IR 20 mg', 'otherNumAtRisk': 17, 'otherNumAffected': 9, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'otherNumAtRisk': 17, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Obsessive-Compulsive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Micturition Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Feeling Jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Heart Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Sensation of Heaviness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Power of Attention Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': 'half an hour prior to dosing', 'categories': [{'measurements': [{'value': '1260.7', 'spread': '34.000', 'groupId': 'OG000'}, {'value': '1324.1', 'spread': '47.142', 'groupId': 'OG001'}, {'value': '1272.8', 'spread': '33.729', 'groupId': 'OG002'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '1244.6', 'spread': '32.887', 'groupId': 'OG000'}, {'value': '1307.4', 'spread': '42.908', 'groupId': 'OG001'}, {'value': '1253.1', 'spread': '24.174', 'groupId': 'OG002'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '1315.5', 'spread': '67.246', 'groupId': 'OG000'}, {'value': '1255.0', 'spread': '33.905', 'groupId': 'OG001'}, {'value': '1296.2', 'spread': '39.808', 'groupId': 'OG002'}]}]}, {'title': '3 hours post-dose', 'categories': [{'measurements': [{'value': '1219.1', 'spread': '33.428', 'groupId': 'OG000'}, {'value': '1229.6', 'spread': '37.865', 'groupId': 'OG001'}, {'value': '1301.0', 'spread': '40.864', 'groupId': 'OG002'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '1225.9', 'spread': '40.192', 'groupId': 'OG000'}, {'value': '1236.5', 'spread': '36.839', 'groupId': 'OG001'}, {'value': '1275.4', 'spread': '35.302', 'groupId': 'OG002'}]}]}, {'title': '5 hours post-dose', 'categories': [{'measurements': [{'value': '1179.6', 'spread': '35.022', 'groupId': 'OG000'}, {'value': '1251.4', 'spread': '42.607', 'groupId': 'OG001'}, {'value': '1330.3', 'spread': '49.623', 'groupId': 'OG002'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '1212.0', 'spread': '36.113', 'groupId': 'OG000'}, {'value': '1259.3', 'spread': '35.883', 'groupId': 'OG001'}, {'value': '1304.5', 'spread': '43.802', 'groupId': 'OG002'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '1232.4', 'spread': '48.183', 'groupId': 'OG000'}, {'value': '1239.3', 'spread': '38.465', 'groupId': 'OG001'}, {'value': '1262.1', 'spread': '40.795', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '1199.3', 'spread': '35.947', 'groupId': 'OG000'}, {'value': '1270.1', 'spread': '39.539', 'groupId': 'OG001'}, {'value': '1270.5', 'spread': '44.814', 'groupId': 'OG002'}]}]}, {'title': '16 hours post-dose', 'categories': [{'measurements': [{'value': '1202.6', 'spread': '37.135', 'groupId': 'OG000'}, {'value': '1255.9', 'spread': '36.378', 'groupId': 'OG001'}, {'value': '1270.3', 'spread': '48.581', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7', 'description': 'The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.'}, {'type': 'SECONDARY', 'title': 'Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '66.16', 'spread': '2.927', 'groupId': 'OG000'}, {'value': '63.39', 'spread': '3.319', 'groupId': 'OG001'}, {'value': '64.92', 'spread': '2.775', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '65.78', 'spread': '3.029', 'groupId': 'OG000'}, {'value': '64.45', 'spread': '2.483', 'groupId': 'OG001'}, {'value': '66.33', 'spread': '2.398', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD'}, {'type': 'SECONDARY', 'title': 'CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '64.21', 'spread': '2.996', 'groupId': 'OG000'}, {'value': '63.62', 'spread': '3.372', 'groupId': 'OG001'}, {'value': '63.28', 'spread': '3.063', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '65.08', 'spread': '2.837', 'groupId': 'OG000'}, {'value': '63.41', 'spread': '2.763', 'groupId': 'OG001'}, {'value': '65.74', 'spread': '2.597', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD'}, {'type': 'SECONDARY', 'title': 'CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '55.46', 'spread': '2.931', 'groupId': 'OG000'}, {'value': '54.58', 'spread': '3.470', 'groupId': 'OG001'}, {'value': '54.66', 'spread': '3.421', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '57.82', 'spread': '3.479', 'groupId': 'OG000'}, {'value': '51.53', 'spread': '2.802', 'groupId': 'OG001'}, {'value': '55.78', 'spread': '2.773', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD'}, {'type': 'SECONDARY', 'title': 'CAARS-S:S Subscale T-Score: Problems With Self-Concept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '58.71', 'spread': '3.533', 'groupId': 'OG000'}, {'value': '59.78', 'spread': '3.390', 'groupId': 'OG001'}, {'value': '58.40', 'spread': '3.279', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '59.68', 'spread': '3.841', 'groupId': 'OG000'}, {'value': '59.54', 'spread': '3.574', 'groupId': 'OG001'}, {'value': '59.68', 'spread': '3.055', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD'}, {'type': 'SECONDARY', 'title': 'CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDX 50 mg'}, {'id': 'OG001', 'title': 'MAS-IR 20 mg'}, {'id': 'OG002', 'title': 'Placebo'}], 'classes': [{'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '64.82', 'spread': '3.147', 'groupId': 'OG000'}, {'value': '63.90', 'spread': '3.766', 'groupId': 'OG001'}, {'value': '64.59', 'spread': '3.681', 'groupId': 'OG002'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '66.56', 'spread': '3.714', 'groupId': 'OG000'}, {'value': '63.09', 'spread': '2.945', 'groupId': 'OG001'}, {'value': '64.85', 'spread': '3.118', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo', 'description': 'Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo'}, {'id': 'FG001', 'title': 'LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg', 'description': 'LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo'}, {'id': 'FG002', 'title': 'Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg', 'description': 'LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo'}, {'id': 'FG003', 'title': 'Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg', 'description': 'LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo'}, {'id': 'FG004', 'title': 'MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo', 'description': 'MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo'}, {'id': 'FG005', 'title': 'MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg', 'description': 'MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo'}, {'id': 'BG001', 'title': 'LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg'}, {'id': 'BG002', 'title': 'Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg'}, {'id': 'BG003', 'title': 'Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg'}, {'id': 'BG004', 'title': 'MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo'}, {'id': 'BG005', 'title': 'MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '1.00', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '6.70', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '6.11', 'groupId': 'BG002'}, {'value': '31.3', 'spread': '11.37', 'groupId': 'BG003'}, {'value': '53.0', 'spread': '0.00', 'groupId': 'BG004'}, {'value': '30.0', 'spread': '11.36', 'groupId': 'BG005'}, {'value': '30.8', 'spread': '10.75', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Between 18 and 55 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': '>=56 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2010-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2009-11-09', 'resultsFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-01-28', 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Power of Attention Score', 'timeFrame': 'pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7', 'description': 'The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.'}, {'measure': 'CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.'}, {'measure': 'CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.'}, {'measure': 'CAARS-S:S Subscale T-Score: Problems With Self-Concept', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.'}, {'measure': 'CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index', 'timeFrame': '2 and 14 hours post-dose on Day 7', 'description': 'Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \\* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.'}]}, 'conditionsModule': {'keywords': ['ADHD'], 'conditions': ['Attention-Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '24297663', 'type': 'RESULT', 'citation': 'Martin PT, Corcoran M, Zhang P, Katic A. Randomized, double-blind, placebo-controlled, crossover study of the effects of lisdexamfetamine dimesylate and mixed amphetamine salts on cognition throughout the day in adults with attention-deficit/hyperactivity disorder. Clin Drug Investig. 2014 Feb;34(2):147-57. doi: 10.1007/s40261-013-0156-z.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA recall information'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.\n2. Subject has been previously treated for ADHD with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the Investigator.\n3. Subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. For a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands."}, 'identificationModule': {'nctId': 'NCT01010750', 'briefTitle': 'Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase I, Randomized, Double Blind, Three-Period Crossover, Estimation Study Using Lisdexamfetamine Dimesylate, Immediate Release Mixed Amphetamine Salts and Placebo to Evaluate the Utility of a Standardized Computer Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD489-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LDX + MAS-IR Placebo', 'description': 'Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo', 'interventionNames': ['Drug: Lisdexamfetamine Dimesylate (LDX)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAS-IR + LDX Placebo', 'description': 'Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo', 'interventionNames': ['Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo', 'interventionNames': ['Drug: LDX Placebo + MAS-IR Placebo']}], 'interventions': [{'name': 'Lisdexamfetamine Dimesylate (LDX)', 'type': 'DRUG', 'description': 'Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo', 'armGroupLabels': ['LDX + MAS-IR Placebo']}, {'name': 'Immediate Release Mixed Amphetamine Salts (MAS-IR)', 'type': 'DRUG', 'description': 'Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo', 'armGroupLabels': ['MAS-IR + LDX Placebo']}, {'name': 'LDX Placebo + MAS-IR Placebo', 'type': 'DRUG', 'description': 'Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Claghorn-Lesem Research Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}