Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-04 @ 8:53 AM
Study NCT ID:
NCT01435759
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2011-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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 Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.', 'eventGroups': [{'id': 'EG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).', 'otherNumAtRisk': 78, 'otherNumAffected': 20, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.', 'otherNumAtRisk': 77, 'otherNumAffected': 30, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.', 'otherNumAtRisk': 76, 'otherNumAffected': 29, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.', 'otherNumAtRisk': 78, 'otherNumAffected': 36, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.', 'otherNumAtRisk': 80, 'otherNumAffected': 44, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'OG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'OG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'OG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'OG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '9.55', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '8.58', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '9.17', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '7.82', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '10.55', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.', 'statisticalMethod': 'MCP-Mod Analysis Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'OG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'OG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'OG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'OG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.64', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '7.39', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '6.58', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '7.45', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'MCP-Mod Analysis', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.', 'statisticalMethod': 'Least Squares Means', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'estimateComment': 'The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'estimateComment': 'The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'OG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'OG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'OG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'OG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '9.95', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.32', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '8.08', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '9.80', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '11.25', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.'}, {'type': 'PRIMARY', 'title': 'Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'OG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'OG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'OG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'OG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '-3.5'}, {'value': '-6.7', 'groupId': 'OG001', 'lowerLimit': '-8.6', 'upperLimit': '-4.9'}, {'value': '-5.3', 'groupId': 'OG002', 'lowerLimit': '-7.1', 'upperLimit': '-3.4'}, {'value': '-6.1', 'groupId': 'OG003', 'lowerLimit': '-8.1', 'upperLimit': '-4.1'}, {'value': '-6.3', 'groupId': 'OG004', 'lowerLimit': '-8.2', 'upperLimit': '-4.4'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-.11', 'pValueComment': 'Any p-value \\<=0.10 indicates successful establishment of dose-response relationship.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.07', 'estimateComment': 'The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.', 'groupDescription': 'Analysis of Dose-Response Using the MCP-Mod Analysis Method', 'statisticalMethod': 'MCP-Mod Analysis Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.942', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.43', 'pValueComment': 'Any p-value \\<=0.10 indicates successful establishment of dose-response relationship.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'estimateComment': 'The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.', 'groupDescription': 'Analysis of Dose-Response Using the MCP-Mod Analysis Method.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.995', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.21', 'pValueComment': 'Any p-value \\<=0.10 indicates successful establishment of dose-response relationship.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'estimateComment': 'The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.', 'groupDescription': 'Analysis of Dose-Response Using the MCP-Mod Analysis Method.', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.'}, {'pValue': '0.978', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Least Squares Means', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-.32', 'pValueComment': 'Any p-value \\<=0.10 indicates successful establishment of dose-response relationship.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.07', 'estimateComment': 'The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.', 'groupDescription': 'Analysis of Dose-Response Using the MCP-Mod Analysis Method', 'statisticalMethod': 'MCP-Mod Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Augmentation Baseline (Week 8) to Week 16', 'description': 'MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antidepressant + Single-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).'}, {'id': 'FG001', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'FG002', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'FG003', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'FG004', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'FG005', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}], 'periods': [{'title': 'Antidepressant Lead-in Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of these 1197 subjects, 19 subjects were not dosed.', 'groupId': 'FG000', 'numSubjects': '1197'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '855'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Met BP or Pulse Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'These subjects were not included in the Safety Dose Response Evaluable Set or Safety Analysis Set.', 'groupId': 'FG000', 'numSubjects': '463'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'comment': 'One subject was not dosed.', 'groupId': 'FG002', 'numSubjects': '78'}, {'comment': 'Two subjects were not dosed.', 'groupId': 'FG003', 'numSubjects': '78'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '69'}, {'groupId': 'FG005', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Met BP or Pulse Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '389', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Antidepressant + Double-blind Placebo', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).'}, {'id': 'BG001', 'title': 'Antidepressant + Double-blind SPD489 10mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.'}, {'id': 'BG002', 'title': 'Antidepressant + Double-blind SPD489 30mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.'}, {'id': 'BG003', 'title': 'Antidepressant + Double-blind SPD489 50mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.'}, {'id': 'BG004', 'title': 'Antidepressant + Double-blind SPD489 70mg', 'description': 'Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '10.48', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '11.83', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '12.06', 'groupId': 'BG002'}, {'value': '43.8', 'spread': '12.4', 'groupId': 'BG003'}, {'value': '41.5', 'spread': '10.81', 'groupId': 'BG004'}, {'value': '42.3', 'spread': '11.61', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-55', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '332', 'groupId': 'BG005'}]}]}, {'title': '56-65', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '264', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '125', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}, {'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'CHILE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '333', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an adverse event \\[AE\\] or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2011-09-15', 'resultsFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2011-09-16', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-03', 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)', 'timeFrame': 'Augmentation Baseline (Week 8) to Week 16', 'description': 'MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.'}], 'secondaryOutcomes': [{'measure': 'Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16'}, {'measure': 'Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16'}, {'measure': 'Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16', 'timeFrame': 'From Augmentation Baseline (Week 8) to Week 16'}]}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '28857719', 'type': 'RESULT', 'citation': 'Richards C, Iosifescu DV, Mago R, Sarkis E, Reynolds J, Geibel B, Dauphin M. A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. J Psychopharmacol. 2017 Sep;31(9):1190-1203. doi: 10.1177/0269881117722998. Epub 2017 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. The purpose of this study is to help answer the following questions:\n\n* How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it?\n* Can SPD489 help patients with depression who are also taking an antidepressant?\n* How much SPD489 should be given to patients with depression who are also taking an antidepressant?\n* How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Subject is able to provide written, personally signed and dated informed consent to participate in the study before completing any study-related procedures.\n2. Subject is between 18-65 years of age.\n3. Subject has a primary diagnosis of non-psychotic MDD.\n4. Subject has a MADRS total score 24\n5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.\n6. Subject, who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements.\n7. Subject is able to swallow a capsule.\n\nExclusion Criteria\n\n1. Subject whose current episode of MDD has not responded to an adequate treatment regimen.\n2. Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.\n3. Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.\n4. Subject has been hospitalized (within the last 12 months) for their current MDD episode.\n5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).\n6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.\n7. Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.\n8. Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.\n9. Subject has a concurrent chronic or acute illness or unstable medical condition.\n10. Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions.\n11. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.\n12. Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.\n13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.\n14. Subject has glaucoma.\n15. Subject has any clinically significant ECG or clinical laboratory abnormalities at the Screening Visit.\n16. Subject has a history of moderate to severe hypertension.\n17. Current use of any other medication (including over-the-counter \\[OTC\\], herbal or homeopathic preparations) that has central nervous system effects.\n18. Subject has the potential to need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.\n19. Subject has had electroconvulsive therapy for the current depressive episode 3 months prior to the Lead-in Baseline Visit.\n20. The subject has a known or suspected intolerance or hypersensitivity to the investigational product.\n21. The subject has a known or suspected intolerance or hypersensitivity to any of the possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended release.\n22. Subject has a positive urine drug result.\n23. Subject has a body mass index of \\<18.5 or \\>40.\n24. Subject is female and is pregnant or nursing.\n25. Subject has participated in another clinical study involving SPD489/NRP104 or has previously used commercial lisdexamfetamine dimesylate."}, 'identificationModule': {'nctId': 'NCT01435759', 'briefTitle': 'SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant', 'orgStudyIdInfo': {'id': 'SPD489-209'}, 'secondaryIdInfos': [{'id': '2011-003615-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antidepressant + SPD489 10 mg', 'interventionNames': ['Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Antidepressant + SPD489 30 mg', 'interventionNames': ['Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Antidepressant + SPD489 50 mg', 'interventionNames': ['Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Antidepressant + SPD489 70 mg', 'interventionNames': ['Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Antidepressant + Placebo', 'interventionNames': ['Drug: Antidepressant + Placebo']}], 'interventions': [{'name': 'Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks', 'armGroupLabels': ['Antidepressant + SPD489 10 mg']}, {'name': 'Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks', 'armGroupLabels': ['Antidepressant + SPD489 30 mg']}, {'name': 'Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks', 'armGroupLabels': ['Antidepressant + SPD489 50 mg']}, {'name': 'Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks', 'armGroupLabels': ['Antidepressant + SPD489 70 mg']}, {'name': 'Antidepressant + Placebo', 'type': 'DRUG', 'description': 'oral, once daily for 8 weeks', 'armGroupLabels': ['Antidepressant + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Psychiatric Clinic Clinical Research Trials', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'South Coast Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Shanti Clinical Trials', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovation, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Irvine Center for Clinical Research', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90631', 'city': 'La Habra', 'state': 'California', 'country': 'United States', 'facility': 'Omega Clinical Trials', 'geoPoint': {'lat': 33.93196, 'lon': -117.94617}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Provate Practice of Andrew Leuchter, MD', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'PCSD - 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