Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-10 @ 2:48 PM
Study NCT ID:
NCT00672958
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2008-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating 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'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are defined as adverse events whose onset occurred or intensity increased after the first dose of double-blind study drug through 30 days after permanent discontinuation of double-blind study drug.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.', 'otherNumAtRisk': 298, 'otherNumAffected': 142, 'seriousNumAtRisk': 298, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.', 'otherNumAtRisk': 299, 'otherNumAffected': 168, 'seriousNumAtRisk': 299, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}], 'seriousEvents': [{'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Puncture site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.87', 'spread': '0.662', 'groupId': 'OG000'}, {'value': '-14.61', 'spread': '0.650', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '1.01', 'pValueComment': 'Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \\>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.', 'groupDescription': 'Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '-6.03', 'spread': '0.394', 'groupId': 'OG000'}, {'value': '-5.96', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n= 286, 291)', 'categories': [{'measurements': [{'value': '-9.30', 'spread': '0.505', 'groupId': 'OG000'}, {'value': '-9.05', 'spread': '0.496', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n= 286, 292)', 'categories': [{'measurements': [{'value': '-11.05', 'spread': '0.545', 'groupId': 'OG000'}, {'value': '-11.73', 'spread': '0.536', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n= 286, 292)', 'categories': [{'measurements': [{'value': '-12.33', 'spread': '0.579', 'groupId': 'OG000'}, {'value': '-12.66', 'spread': '0.568', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=286, 292)', 'categories': [{'measurements': [{'value': '-13.11', 'spread': '0.628', 'groupId': 'OG000'}, {'value': '-13.98', 'spread': '0.617', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '1.10', 'groupDescription': 'Comparison of change from Baseline at Week 1.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '1.59', 'groupDescription': 'Change from Baseline at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.356', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '0.76', 'groupDescription': 'Change from Baseline at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '1.19', 'groupDescription': 'Change from Baseline at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.52', 'ciUpperLimit': '0.79', 'groupDescription': 'Change from Baseline at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders in HAM-D24 Total Score by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=286, 291)', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=286, 292)', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '32.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=286, 292)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=286, 292)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=286, 292)', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': 'A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in MADRS Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Sustained Response in HAM-D24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'description': 'A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Participants with missing values were classified as nonsustained responders/remitters.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '-6.88', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '0.412', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=286, 291)', 'categories': [{'measurements': [{'value': '-10.57', 'spread': '0.530', 'groupId': 'OG000'}, {'value': '-9.82', 'spread': '0.523', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=286, 292)', 'categories': [{'measurements': [{'value': '-12.48', 'spread': '0.583', 'groupId': 'OG000'}, {'value': '-12.76', 'spread': '0.575', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=286, 292)', 'categories': [{'measurements': [{'value': '-13.72', 'spread': '0.624', 'groupId': 'OG000'}, {'value': '-13.70', 'spread': '0.615', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=286, 292)', 'categories': [{'measurements': [{'value': '-14.40', 'spread': '0.673', 'groupId': 'OG000'}, {'value': '-15.12', 'spread': '0.664', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=286, 292)', 'categories': [{'measurements': [{'value': '-15.48', 'spread': '0.708', 'groupId': 'OG000'}, {'value': '-15.80', 'spread': '0.698', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hamilton Anxiety Scale (HAM-A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.288', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '0.284', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=286, 291)', 'categories': [{'measurements': [{'value': '-4.92', 'spread': '0.343', 'groupId': 'OG000'}, {'value': '-4.77', 'spread': '0.338', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=286, 292)', 'categories': [{'measurements': [{'value': '-6.52', 'spread': '0.393', 'groupId': 'OG000'}, {'value': '-6.88', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=286, 292)', 'categories': [{'measurements': [{'value': '-7.60', 'spread': '0.419', 'groupId': 'OG000'}, {'value': '-7.84', 'spread': '0.413', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 4 and 6.', 'description': 'The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Scale-Severity of Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=286, 291)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.060', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=286, 292)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=286, 292)', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=286, 292)', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.077', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=286, 292)', 'categories': [{'measurements': [{'value': '-1.46', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.083', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression Scale-Global Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=281, 286)', 'categories': [{'measurements': [{'value': '3.38', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '0.047', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=286, 291)', 'categories': [{'measurements': [{'value': '3.09', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.061', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=286, 292)', 'categories': [{'measurements': [{'value': '2.90', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=286, 292)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.069', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=286, 292)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=286, 292)', 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.075', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': "The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Week 1 (n=279, 286)', 'categories': [{'measurements': [{'value': '-2.81', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '0.210', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=284, 292)', 'categories': [{'measurements': [{'value': '-4.18', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '-4.05', 'spread': '0.267', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=284, 292)', 'categories': [{'measurements': [{'value': '-4.56', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '-4.97', 'spread': '0.307', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 6.', 'description': "The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Physical functioning', 'categories': [{'measurements': [{'value': '5.47', 'spread': '1.277', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '1.264', 'groupId': 'OG001'}]}]}, {'title': 'Role - physical', 'categories': [{'measurements': [{'value': '11.73', 'spread': '1.569', 'groupId': 'OG000'}, {'value': '14.41', 'spread': '1.549', 'groupId': 'OG001'}]}]}, {'title': 'Bodily pain', 'categories': [{'measurements': [{'value': '10.77', 'spread': '1.460', 'groupId': 'OG000'}, {'value': '10.39', 'spread': '1.445', 'groupId': 'OG001'}]}]}, {'title': 'General health', 'categories': [{'measurements': [{'value': '7.65', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '0.975', 'groupId': 'OG001'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '18.00', 'spread': '1.455', 'groupId': 'OG000'}, {'value': '17.34', 'spread': '1.440', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning', 'categories': [{'measurements': [{'value': '21.34', 'spread': '1.687', 'groupId': 'OG000'}, {'value': '22.01', 'spread': '1.667', 'groupId': 'OG001'}]}]}, {'title': 'Role - emotional', 'categories': [{'measurements': [{'value': '19.43', 'spread': '1.756', 'groupId': 'OG000'}, {'value': '20.76', 'spread': '1.732', 'groupId': 'OG001'}]}]}, {'title': 'Mental health', 'categories': [{'measurements': [{'value': '18.98', 'spread': '1.401', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '1.385', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set where Baseline SF-36 data were available; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.61', 'spread': '0.548', 'groupId': 'OG000'}, {'value': '-6.69', 'spread': '0.557', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set where data were available; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'classes': [{'title': 'Baseline: Any resource use', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Any hospitalization-related services', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Hospitalization related to depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Any sick leave', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Sick leave related to depression', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Any resource use', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Any hospitalization-related service', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Hospitalization related to depression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Any sick leave', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Sick leave related to depression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 6', 'description': 'Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'FG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'Safety Set', 'achievements': [{'comment': 'All randomized patients who received at least 1 dose of double-blind study drug.', 'groupId': 'FG000', 'numSubjects': '298'}, {'comment': 'All randomized patients who received at least 1 dose of double-blind study drug.', 'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'Full Analysis Set', 'achievements': [{'comment': 'All safety set patients who had at least 1 valid postbaseline primary efficacy assessment.', 'groupId': 'FG000', 'numSubjects': '286'}, {'comment': 'All safety set patients who had at least 1 valid postbaseline primary efficacy assessment.', 'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol deviations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Voluntary withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 47 investigative sites in the United States from 07 April 2008 to 12 November 2008.', 'preAssignmentDetails': 'Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 2 treatment groups, once a day placebo or 5 mg vortioxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.'}, {'id': 'BG001', 'title': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '12.70', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '13.04', 'groupId': 'BG001'}, {'value': '42.4', 'spread': '12.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian (White, including Hispanic)', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/ Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic/Non-Latino', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '89.53', 'spread': '23.326', 'groupId': 'BG000'}, {'value': '86.63', 'spread': '23.528', 'groupId': 'BG001'}, {'value': '88.08', 'spread': '23.453', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.36', 'spread': '9.815', 'groupId': 'BG000'}, {'value': '168.67', 'spread': '9.815', 'groupId': 'BG001'}, {'value': '169.51', 'spread': '9.843', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.84', 'spread': '7.675', 'groupId': 'BG000'}, {'value': '30.48', 'spread': '8.217', 'groupId': 'BG001'}, {'value': '30.66', 'spread': '7.946', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '97.58', 'spread': '17.757', 'groupId': 'BG000'}, {'value': '96.22', 'spread': '18.961', 'groupId': 'BG001'}, {'value': '96.90', 'spread': '18.366', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking classification', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol consumption', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'Once monthly or less often', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'Once per week', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': '2-to-6 times/week', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Daily', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '24-item Hamilton Depression Scale total score', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '5.50', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '5.42', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '5.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montgomery Åsberg Depression Rating Scale (MADRS) total score', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '3.41', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '3.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Anxiety Scale Total Score', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '6.19', 'groupId': 'BG000'}, {'value': '19.3', 'spread': '5.24', 'groupId': 'BG001'}, {'value': '19.4', 'spread': '5.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression - Severity scale score', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '0.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-24', 'studyFirstSubmitDate': '2008-05-02', 'resultsFirstSubmitDate': '2013-04-19', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-24', 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.'}, {'measure': 'Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders in HAM-D24 Total Score by Study Visit', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': 'A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.'}, {'measure': 'Percentage of Participants in MADRS Remission at Week 6', 'timeFrame': 'Week 6', 'description': 'Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.'}, {'measure': 'Percentage of Participants With a Sustained Response in HAM-D24', 'timeFrame': 'Baseline to Week 6', 'description': 'A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.'}, {'measure': 'Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}, {'measure': 'Change From Baseline in Hamilton Anxiety Scale (HAM-A)', 'timeFrame': 'Baseline and Weeks 1, 2, 4 and 6.', 'description': 'The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}, {'measure': 'Change From Baseline in Clinical Global Impression Scale-Severity of Illness', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate."}, {'measure': 'Clinical Global Impression Scale-Global Improvement Scale', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5 and 6.', 'description': "The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate."}, {'measure': 'Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)', 'timeFrame': 'Baseline and Weeks 1, 4 and 6.', 'description': "The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate."}, {'measure': 'Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}, {'measure': 'Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire', 'timeFrame': 'Baseline and Week 6', 'description': 'Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Depression', 'Drug Therapy', 'Major Depressive Episode'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '22963932', 'type': 'RESULT', 'citation': 'Jain R, Mahableshwarkar AR, Jacobsen PL, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol. 2013 Mar;16(2):313-21. doi: 10.1017/S1461145712000727. Epub 2012 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.', 'detailedDescription': 'The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.\n\nThe study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):\n\n* Vortioxetine 5 mg\n* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.\n\nAll participants were asked to take one capsule at the same time each day throughout the study.\n\nThis multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 94 days. Participants made 8 visits to the clinic, and were contacted by telephone 1 week, 2 weeks, and 4 weeks after the last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Suffers from a major depressive episode (MDE) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.\n* The reported duration of the current MDE is at least 3 months.\n* Has a Montgomery Åsberg Depression Rating Scale total score greater than or equal to 30.\n* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.\n\nExclusion Criteria:\n\n* Has received any investigational compound less than 30 days before Screening or 5 half-lives prior to Screening, whichever is longer.\n* Has received Lu AA21004 in a previous clinical study.\n* Has 1 or more the following:\n\n * Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview)\n * Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.\n * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.\n * Presence or history of a clinically significant neurological disorder (including epilepsy).\n * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).\n * Any Axis II disorder that might compromise the study.\n* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:\n\n * Narcotic analgesics\n * Nonsteroidal anti-inflammatory drugs\n * Rifampin\n * Macrolide antibiotics\n * Hormones (only thyroid hormone replacement, contraceptives \\[oral, patch\\], estrogen and progesterone replacement therapy are allowed in chronic use)\n * Hypoglycemic agents (chronic use is allowed)\n * Insulin (chronic use is allowed)\n * Systemic steroids\n * Quinidine\n * Antineoplastics\n * Antiobesity agents\n* Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.\n* The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.\n* Has received electroconvulsive therapy within 6 months prior to Screening.\n* Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.\n* Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.\n* Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n* Has a serum creatinine greater than 1.5 times the upper limits of normal.\n* Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include basal cell or Stage I squamous cell carcinoma of the skin.\n* Has clinically significant abnormal vital signs as determined by the investigator.\n* Has an abnormal electrocardiogram determined by the central reader and confirmed as clinically significant by the investigator.\n* Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.\n* Has a thyroid stimulating hormone value outside the normal range at Screening Visit that is determined to be clinically significant by the investigator.\n* Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.\n* Has previously enrolled in this study."}, 'identificationModule': {'nctId': 'NCT00672958', 'briefTitle': 'Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study Comparing the Efficacy and Safety of Lu AA21004 Versus Placebo in Acute Treatment of Adults With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LuAA21004_303'}, 'secondaryIdInfos': [{'id': 'U1111-1114-2328', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine', 'description': 'Vortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks.', 'interventionNames': ['Drug: Vortioxetine']}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'otherNames': ['Lu AA21004', 'Brintellix®'], 'description': 'Encapsulated immediate-release tablets.', 'armGroupLabels': ['Vortioxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vortioxetine placebo-matching capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Encino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Hoffman Estate', 'state': 'Illinois', 'country': 'United States'}, {'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.78922, 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