Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00731120
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2008-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.', '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 8 weeks.', 'otherNumAtRisk': 153, 'otherNumAffected': 70, 'seriousNumAtRisk': 153, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks', 'otherNumAtRisk': 151, 'otherNumAffected': 72, 'seriousNumAtRisk': 151, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 152, 'otherNumAffected': 83, 'seriousNumAtRisk': 152, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.87', 'spread': '0.584', 'groupId': 'OG000'}, {'value': '-10.75', 'spread': '0.569', 'groupId': 'OG001'}, {'value': '-10.68', 'spread': '0.581', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.279', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '0.71', 'pValueComment': 'Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.803', 'groupDescription': 'P-values were tested at the 5% significance level (ie, statistical significance if P\\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.306', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '0.74', 'pValueComment': 'Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.791', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', '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 (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 (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Week 1 (n=147, 142, 143)', 'categories': [{'measurements': [{'value': '-5.07', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '-5.29', 'spread': '0.423', 'groupId': 'OG001'}, {'value': '-5.30', 'spread': '0.433', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-7.41', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '-8.11', 'spread': '0.488', 'groupId': 'OG001'}, {'value': '-8.05', 'spread': '0.499', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-8.88', 'spread': '0.566', 'groupId': 'OG000'}, {'value': '-9.45', 'spread': '0.551', 'groupId': 'OG001'}, {'value': '-9.54', 'spread': '0.564', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-9.54', 'spread': '0.565', 'groupId': 'OG000'}, {'value': '-10.35', 'spread': '0.550', 'groupId': 'OG001'}, {'value': '-10.50', 'spread': '0.563', 'groupId': 'OG002'}]}]}], '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. 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-A Total Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}, {'value': '41.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. 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 (symptoms absent) to 56 (maximum severity).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in HAM-A Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '21.5', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. 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 (symptoms absent) to 56 (maximum severity).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Week 1 (n=146, 141, 143)', 'categories': [{'measurements': [{'value': '3.35', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '0.071', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=148, 143, 146)', 'categories': [{'measurements': [{'value': '2.99', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '2.92', 'spread': '0.083', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '2.87', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '2.69', 'spread': '0.088', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '2.68', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '0.088', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '2.51', 'spread': '0.095', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 4, 6 and 8.', '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 adjusting for Baseline CGI-S score, center, and treatment.", '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 (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Week 1 (n=146, 140, 143)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '0.054', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=148, 143, 146)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '0.071', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '0.081', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.082', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-1.14', 'spread': '0.090', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 4, 6 and 8.', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant'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 adjusting for Baseline score, center, and treatment.", '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 Hospital Anxiety and Depression (HAD) Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Anxiety Scale at Week 1 (n=147, 142, 143)', 'categories': [{'measurements': [{'value': '-1.64', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.258', 'groupId': 'OG001'}, {'value': '-2.03', 'spread': '0.264', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety Scale at Week 4 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-2.81', 'spread': '0.343', 'groupId': 'OG000'}, {'value': '-3.66', 'spread': '0.333', 'groupId': 'OG001'}, {'value': '-3.39', 'spread': '0.339', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety Scale at Week 8 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-3.63', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '-4.20', 'spread': '0.361', 'groupId': 'OG002'}]}]}, {'title': 'Depression Scale at Week 1 (n=147, 142, 143)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.226', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '0.220', 'groupId': 'OG001'}, {'value': '-1.15', 'spread': '0.225', 'groupId': 'OG002'}]}]}, {'title': 'Depression Scale at Week 4 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-1.66', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '-2.23', 'spread': '0.265', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '0.271', 'groupId': 'OG002'}]}]}, {'title': 'Depression Scale at Week 8 (n=148, 144, 146)', 'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.308', 'groupId': 'OG000'}, {'value': '-2.56', 'spread': '0.300', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '0.306', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 8.', 'description': 'The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). 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 Deviation', '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 Sheehan Disability Scale (SDS) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.26', 'spread': '0.617', 'groupId': 'OG000'}, {'value': '-5.73', 'spread': '0.623', 'groupId': 'OG001'}, {'value': '-5.24', 'spread': '0.657', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', '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 with available data at Baseline; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short-form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Physical functioning subscore', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.513', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '1.478', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '1.517', 'groupId': 'OG002'}]}]}, {'title': 'Role - physical subscore', 'categories': [{'measurements': [{'value': '4.44', 'spread': '2.018', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '1.972', 'groupId': 'OG001'}, {'value': '6.17', 'spread': '2.026', 'groupId': 'OG002'}]}]}, {'title': 'Bodily pain subscore', 'categories': [{'measurements': [{'value': '5.90', 'spread': '1.901', 'groupId': 'OG000'}, {'value': '10.67', 'spread': '1.855', 'groupId': 'OG001'}, {'value': '8.12', 'spread': '1.905', 'groupId': 'OG002'}]}]}, {'title': 'General health subscore', 'categories': [{'measurements': [{'value': '4.44', 'spread': '1.289', 'groupId': 'OG000'}, {'value': '7.01', 'spread': '1.258', 'groupId': 'OG001'}, {'value': '5.90', 'spread': '1.292', 'groupId': 'OG002'}]}]}, {'title': 'Vitality subscore', 'categories': [{'measurements': [{'value': '12.35', 'spread': '1.782', 'groupId': 'OG000'}, {'value': '15.62', 'spread': '1.740', 'groupId': 'OG001'}, {'value': '14.33', 'spread': '1.783', 'groupId': 'OG002'}]}]}, {'title': 'Social functioning subscore', 'categories': [{'measurements': [{'value': '15.35', 'spread': '2.075', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '2.025', 'groupId': 'OG001'}, {'value': '17.56', 'spread': '2.070', 'groupId': 'OG002'}]}]}, {'title': 'Role-emotional subscore', 'categories': [{'measurements': [{'value': '15.16', 'spread': '2.076', 'groupId': 'OG000'}, {'value': '21.72', 'spread': '2.028', 'groupId': 'OG001'}, {'value': '16.60', 'spread': '2.081', 'groupId': 'OG002'}]}]}, {'title': 'Mental health subscore', 'categories': [{'measurements': [{'value': '12.93', 'spread': '1.642', 'groupId': 'OG000'}, {'value': '17.25', 'spread': '1.608', 'groupId': 'OG001'}, {'value': '14.74', 'spread': '1.643', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', '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 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 with a Baseline SF-36 measurement; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'classes': [{'title': 'Baseline: Any resource use', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Any hospitalization-related services', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Hospitalization related to anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Any sick leave', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Sick leave related to anxiety', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Any resource use', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Any hospitalization-related service', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Hospitalization related to anxiety', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Any sick leave', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Sick leave related to anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors 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 8 weeks.'}, {'id': 'FG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'FG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Deviations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 41 investigative sites in the United States from 17 June 2008 to 16 February 2009.', 'preAssignmentDetails': 'Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of three treatment groups, once a day placebo or 2.5 or 10 mg vortioxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'BG001', 'title': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks'}, {'id': 'BG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '13.45', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '13.81', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '14.99', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '14.15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≤55 years', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '383', 'groupId': 'BG003'}]}]}, {'title': '>55 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '304', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic/Non-Latino', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '411', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian (White, including Hispanic)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '327', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.66', 'spread': '20.731', 'groupId': 'BG000'}, {'value': '84.48', 'spread': '22.727', 'groupId': 'BG001'}, {'value': '85.67', 'spread': '23.249', 'groupId': 'BG002'}, {'value': '84.27', 'spread': '22.245', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.31', 'spread': '9.994', 'groupId': 'BG000'}, {'value': '168.63', 'spread': '8.932', 'groupId': 'BG001'}, {'value': '168.86', 'spread': '10.032', 'groupId': 'BG002'}, {'value': '168.60', 'spread': '9.649', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.10', 'spread': '6.595', 'groupId': 'BG000'}, {'value': '29.69', 'spread': '7.817', 'groupId': 'BG001'}, {'value': '30.04', 'spread': '7.792', 'groupId': 'BG002'}, {'value': '29.61', 'spread': '7.415', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}]}, {'title': 'Once monthly or less often', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}, {'title': 'Once a week', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': '2 to 6 times per week', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Daily', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hamilton Anxiety Scale Total Score', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '3.86', 'groupId': 'BG000'}, {'value': '25.0', 'spread': '3.60', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '3.71', 'groupId': 'BG002'}, {'value': '24.9', 'spread': '3.73', 'groupId': 'BG003'}]}]}], '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 (absent) to 56 (maximum severity).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression - Severity scale score', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.49', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '0.47', 'groupId': 'BG002'}, {'value': '4.3', 'spread': '0.50', 'groupId': 'BG003'}]}]}], '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'}, {'title': 'Hospital Anxiety and Depression - Anxiety subscale', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '3.27', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '3.56', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '3.17', 'groupId': 'BG002'}, {'value': '13.4', 'spread': '3.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression - Depression subscale', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '3.67', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '3.80', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '3.60', 'groupId': 'BG002'}, {'value': '8.3', 'spread': '3.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Hospital Anxiety and Depression (HAD) Depression sub-scale consists of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). The depression subscale focuses on the state of lost interest and diminished pleasure response. Scores are summed and range from 0 to 21 (maximal severity).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montgomery Åsberg Depression Rating Scale (MADRS) total score', 'classes': [{'categories': [{'measurements': [{'value': '12.73', 'spread': '2.417', 'groupId': 'BG000'}, {'value': '12.64', 'spread': '2.502', 'groupId': 'BG001'}, {'value': '13.04', 'spread': '2.521', 'groupId': 'BG002'}, {'value': '12.80', 'spread': '2.481', 'groupId': 'BG003'}]}]}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-25', 'studyFirstSubmitDate': '2008-08-06', 'resultsFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-25', 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score', 'timeFrame': 'Baseline and Week 8', '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 (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed', '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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.'}, {'measure': 'Percentage of Responders in HAM-A Total Score at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. 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 (symptoms absent) to 56 (maximum severity).'}, {'measure': 'Percentage of Participants in HAM-A Remission at Week 8', 'timeFrame': 'Week 8', 'description': 'Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. 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 (symptoms absent) to 56 (maximum severity).'}, {'measure': 'Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed', 'timeFrame': 'Baseline and Weeks 1, 2, 4, 6 and 8.', '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 adjusting for Baseline CGI-S score, center, and treatment."}, {'measure': 'Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)', 'timeFrame': 'Baseline and Weeks 1, 2, 4, 6 and 8.', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant'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 adjusting for Baseline score, center, and treatment."}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression (HAD) Scales', 'timeFrame': 'Baseline and Weeks 1, 4 and 8.', 'description': 'The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were 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) at Week 8', 'timeFrame': 'Baseline and Week 8', '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': 'Change From Baseline in 36-item Short-form Health Survey (SF-36)', 'timeFrame': 'Baseline and Week 8', '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 were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.'}, {'measure': 'Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire', 'timeFrame': 'Baseline and Week 8', 'description': 'Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors 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': ['Generalized Anxiety Disorder', 'Mood Disorder', 'Affective Disorder', 'Anxiety Disorder', 'Drug Therapy'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '24424707', 'type': 'DERIVED', 'citation': 'Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y. A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder. Hum Psychopharmacol. 2014 Jan;29(1):64-72. doi: 10.1002/hup.2371.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.', 'detailedDescription': 'Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.\n\nParticipants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).\n* Has a Hamilton Anxiety Scale total score ≥ 20.\n* Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).\n* Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.\n\nExclusion Criteria:\n\n* Has 1 or more of the following:\n\n * Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview \\[MINI\\]).\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 and participant must have a negative urine drug screen prior to Baseline.\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 taking excluded medications.\n* Has a significant risk of suicide according to the investigator's opinion or has a score ≥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* Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.\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.\n* Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \\> 1.5 times the upper limit of normal.\n* Has a serum creatinine of \\> 1.5 × the upper limit of normal.\n* Has a previous history of cancer that had been in remission for less than 5 years.\n* Has thyroid stimulating hormone value outside the normal range.\n* Has an abnormal electrocardiogram."}, 'identificationModule': {'nctId': 'NCT00731120', 'briefTitle': 'Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'LuAA21004_309'}, 'secondaryIdInfos': [{'id': 'U1111-1114-2380', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 2.5 mg', 'description': 'Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.', 'interventionNames': ['Drug: Vortioxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.', 'interventionNames': ['Drug: Vortioxetine']}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'otherNames': ['Lu AA21004', 'Brintellix®'], 'description': 'Encapsulated vortioxetine immediate-release tablets', 'armGroupLabels': ['Vortioxetine 10 mg', 'Vortioxetine 2.5 mg']}, {'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': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Redlands', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'city': 'Hockessin', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.78761, 'lon': -75.6966}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United 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'geoPoint': {'lat': 42.45008, 'lon': -73.24538}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.73482, 'lon': -73.79347}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Olean', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.07756, 'lon': -78.42974}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Emmaus', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.53954, 'lon': -75.49685}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}], 'overallOfficials': [{'name': 'Medical Director, Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}