Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 6:10 AM
Study NCT ID:
NCT01629966
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069503', 'term': 'Vilazodone Hydrochloride'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com', 'phone': '877-277-8566', 'title': 'Therapeutic Area Head', 'organization': 'Forest Research Institute, Inc'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected until week 8.', 'description': 'The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Dose-matched placebo one per day, oral administration', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 85, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vilazadone 20mg', 'description': 'Vilazodone 20mg once per day, oral administration.', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 123, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vilazodone 40mg', 'description': 'Vilazodone 40mg once per day, oral administration', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 121, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'seriousEvents': [{'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'left carpal canal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo one per day, oral administration'}, {'id': 'OG001', 'title': 'Vilazadone 20mg', 'description': 'Vilazodone 20mg once per day, oral administration.'}, {'id': 'OG002', 'title': 'Vilazodone 40mg', 'description': 'Vilazodone 40mg once per day, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '7.13', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '7.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0830', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '0.17', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0156', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-3.26', 'ciUpperLimit': '-0.34', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo one per day, oral administration'}, {'id': 'OG001', 'title': 'Vilazadone 20mg', 'description': 'Vilazodone 20mg once per day, oral administration.'}, {'id': 'OG002', 'title': 'Vilazodone 40mg', 'description': 'Vilazodone 40mg once per day, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '6.51', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '6.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0536', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.37', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '0.02', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0349', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '-0.11', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).', 'unitOfMeasure': 'Score on Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dose-matched placebo one per day, oral administration'}, {'id': 'FG001', 'title': 'Vilazadone 20mg', 'description': 'Vilazodone 20mg once per day, oral administration.'}, {'id': 'FG002', 'title': 'Vilazodone 40mg', 'description': 'Vilazodone 40mg once per day, oral administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '227'}, {'groupId': 'FG002', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '30'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}, {'value': '673', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Dose-matched placebo one per day, oral administration'}, {'id': 'BG001', 'title': 'Vilazadone 20mg', 'description': 'Vilazodone 20mg once per day, oral administration.'}, {'id': 'BG002', 'title': 'Vilazodone 40mg', 'description': 'Vilazodone 40mg once per day, oral administration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '40.2', 'spread': '13.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': '20-29', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}, {'title': '30-39', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}, {'title': '40-49', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': '50-59', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}, {'title': '≥ 60', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '434', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '594', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '508', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2015-02-27', 'completionDateStruct': {'date': '2014-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2012-06-26', 'dispFirstSubmitQcDate': '2015-02-27', 'resultsFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2012-06-27', 'dispFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-04', 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score', 'timeFrame': 'Baseline to Week 8', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Sheehan Disability Scale (SDS) Total Score', 'timeFrame': 'Baseline to Week 8', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Generalized Anxiety Disorder', 'GAD'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '27486544', 'type': 'DERIVED', 'citation': 'Khan A, Durgam S, Tang X, Ruth A, Mathews M, Gommoll CP. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone. Prim Care Companion CNS Disord. 2016 Apr 28;18(2):10.4088/PCC.15m01904. doi: 10.4088/PCC.15m01904. eCollection 2016.'}, {'pmid': '25891440', 'type': 'DERIVED', 'citation': 'Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female, 18 - 70 years of age\n* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)\n* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)\n\nExclusion Criteria:\n\n* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control\n* History of meeting DSM-IV-TR criteria for any of the following:\n\n * Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode\n * Any depressive episode with psychotic or catatonic features\n * Panic disorder with or without agoraphobia\n * Obsessive-compulsive disorder\n * Schizophrenia, schizoaffective, or other psychotic disorder\n * Bulimia or anorexia nervosa\n * Presence of borderline personality disorder or antisocial personality disorder\n * Mental retardation, dementia, amnesia, or other significant cognitive disorders\n* Patients who are considered a suicide risk'}, 'identificationModule': {'nctId': 'NCT01629966', 'acronym': 'VLZ-MD-05', 'briefTitle': 'Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.', 'orgStudyIdInfo': {'id': 'VLZ-MD-05'}}, 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