Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-31 @ 9:38 PM
Study NCT ID:
NCT02932904
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', '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 study drug on Day 1 until the Follow-up Contact at Week 7', '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 5 weeks.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 36, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 59, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 52, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 40, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Orgasm abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Ejaculation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.27', 'spread': '0.584', 'groupId': 'OG000'}, {'value': '58.56', 'spread': '0.578', 'groupId': 'OG001'}, {'value': '59.43', 'spread': '0.560', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 5', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '0.758', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.752', 'groupId': 'OG001'}, {'value': '-2.51', 'spread': '0.727', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '0.69', 'ciUpperLimit': '4.78', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.040', 'groupDescription': 'ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '3.05', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.017', 'groupDescription': 'ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.453', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '0.436', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.40', 'spread': '0.617', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '-1.55', 'spread': '0.592', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.77', 'spread': '0.661', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.655', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '0.633', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.11', 'spread': '0.688', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.683', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '0.659', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '2.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.627', 'groupDescription': 'Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.09', 'ciUpperLimit': '2.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.612', 'groupDescription': 'Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '2.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.846', 'groupDescription': 'Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '2.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.828', 'groupDescription': 'Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.22', 'ciUpperLimit': '3.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.906', 'groupDescription': 'Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.645', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '2.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.886', 'groupDescription': 'Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.06', 'ciUpperLimit': '3.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.943', 'groupDescription': 'Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '2.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.923', 'groupDescription': 'Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3 and 4', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.440', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '0.457', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.598', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '0.617', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.639', 'groupId': 'OG000'}, {'value': '-2.77', 'spread': '0.661', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.666', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '0.688', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.734', 'groupId': 'OG000'}, {'value': '-3.56', 'spread': '0.758', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.63', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.616', 'groupDescription': 'Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.834', 'groupDescription': 'Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-3.61', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.892', 'groupDescription': 'Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.49', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '-0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.929', 'groupDescription': 'Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.77', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '-0.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.024', 'groupDescription': 'Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 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Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.440', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.453', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '0.436', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.598', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '-1.55', 'spread': '0.592', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.639', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.655', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '0.633', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.666', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.683', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '0.659', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.734', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.752', 'groupId': 'OG001'}, {'value': '-2.51', 'spread': '0.727', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.612', 'groupDescription': 'Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.600', 'groupDescription': 'Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.938', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.828', 'groupDescription': 'Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.592', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.814', 'groupDescription': 'Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.870', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '1.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.886', 'groupDescription': 'Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-3.16', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.871', 'groupDescription': 'Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.923', 'groupDescription': 'Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 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2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. 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'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}, {'value': '6.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '9.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.515', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.037', 'ciUpperLimit': '5.201', 'groupDescription': 'Week 1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.677', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.049', 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'groupDescription': 'Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.160', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.087', 'ciUpperLimit': '1.497', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.744', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.252', 'ciUpperLimit': '2.679', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '0.636', 'ciUpperLimit': '9.317', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.871', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.181', 'ciUpperLimit': '4.261', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.329', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.497', 'ciUpperLimit': '8.037', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.187', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.119', 'ciUpperLimit': '1.514', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.729', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.273', 'ciUpperLimit': '2.476', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '0.739', 'ciUpperLimit': '9.917', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.852', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.266', 'ciUpperLimit': '4.961', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.240', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '0.585', 'ciUpperLimit': '8.472', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.317', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.166', 'ciUpperLimit': '1.789', 'groupDescription': 'Week 5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.790', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.410', 'ciUpperLimit': '3.233', 'groupDescription': 'Week 5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.64', 'ciLowerLimit': '0.888', 'ciUpperLimit': '14.911', 'groupDescription': 'Week 5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.442', 'ciUpperLimit': '8.902', 'groupDescription': 'Week 5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.19', 'ciLowerLimit': '1.027', 'ciUpperLimit': '17.063', 'groupDescription': 'Week 5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 3, 4 and 5', 'description': 'Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG003', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Pleasure Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.066', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.065', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.063', 'groupId': 'OG003'}]}]}, {'title': 'Pleasure Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.081', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.078', 'groupId': 'OG003'}]}]}, {'title': 'Pleasure Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '0.084', 'groupId': 'OG003'}]}]}, {'title': 'Pleasure Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '0.084', 'groupId': 'OG003'}]}]}, {'title': 'Pleasure Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.088', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.085', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Frequency Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.100', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.099', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.096', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Frequency Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.120', 'groupId': 'OG002'}, {'value': '-0.46', 'spread': '0.116', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Frequency Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.132', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.131', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.127', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Frequency Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.130', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.129', 'groupId': 'OG002'}, {'value': '-0.43', 'spread': '0.125', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Frequency Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.144', 'groupId': 'OG002'}, {'value': '-0.49', 'spread': '0.139', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Interest Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.169', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.167', 'groupId': 'OG002'}, {'value': '0.09', 'spread': '0.161', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Interest Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.186', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.185', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '0.179', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Interest Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.198', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '0.191', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Interest Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.206', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.204', 'groupId': 'OG002'}, {'value': '-0.35', 'spread': '0.198', 'groupId': 'OG003'}]}]}, {'title': 'Desire/Interest Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.215', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.223', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.221', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.213', 'groupId': 'OG003'}]}]}, {'title': 'Arousal/Excitement/Erection Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.140', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.135', 'groupId': 'OG003'}]}]}, {'title': 'Arousal/Excitement/Erection Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.181', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.179', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.174', 'groupId': 'OG003'}]}]}, {'title': 'Arousal/Excitement/Erection Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.182', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.188', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.186', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.180', 'groupId': 'OG003'}]}]}, {'title': 'Arousal/Excitement/Erection Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.185', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.179', 'groupId': 'OG003'}]}]}, {'title': 'Arousal/Excitement/Erection Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.200', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.193', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.135', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.134', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.129', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.164', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.162', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '0.157', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.176', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.180', 'groupId': 'OG002'}, {'value': '-0.67', 'spread': '0.175', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.199', 'groupId': 'OG002'}, {'value': '-0.72', 'spread': '0.192', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.214', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.211', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.204', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG003', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Desire Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.234', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.232', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.223', 'groupId': 'OG003'}]}]}, {'title': 'Desire Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.269', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.266', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '0.258', 'groupId': 'OG003'}]}]}, {'title': 'Desire Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.286', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.296', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.293', 'groupId': 'OG002'}, {'value': '-0.77', 'spread': '0.284', 'groupId': 'OG003'}]}]}, {'title': 'Desire Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.297', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.307', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '0.304', 'groupId': 'OG002'}, {'value': '-0.77', 'spread': '0.294', 'groupId': 'OG003'}]}]}, {'title': 'Desire Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.325', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '0.336', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.333', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '0.322', 'groupId': 'OG003'}]}]}, {'title': 'Arousal Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.140', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.135', 'groupId': 'OG003'}]}]}, {'title': 'Arousal Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.181', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.179', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.174', 'groupId': 'OG003'}]}]}, {'title': 'Arousal Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.182', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.188', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.186', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.180', 'groupId': 'OG003'}]}]}, {'title': 'Arousal Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.185', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.179', 'groupId': 'OG003'}]}]}, {'title': 'Arousal Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.200', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.193', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.135', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.134', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.129', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.164', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.162', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '0.157', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.176', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.180', 'groupId': 'OG002'}, {'value': '-0.67', 'spread': '0.175', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.199', 'groupId': 'OG002'}, {'value': '-0.72', 'spread': '0.192', 'groupId': 'OG003'}]}]}, {'title': 'Orgasm/Completion/Ejaculation Score: Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.214', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.211', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.204', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.13', 'spread': '0.614', 'groupId': 'OG000'}, {'value': '58.55', 'spread': '0.582', 'groupId': 'OG001'}, {'value': '59.36', 'spread': '0.576', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 5', 'categories': [{'measurements': [{'value': '-4.01', 'spread': '0.803', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.763', 'groupId': 'OG001'}, {'value': '-2.38', 'spread': '0.754', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.38', 'ciLowerLimit': '1.25', 'ciUpperLimit': '5.51', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.082', 'groupDescription': 'ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '3.73', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.068', 'groupDescription': 'ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mFAS1 included all participants in the FAS except those who had active drug concentrations below the limit of quantification (BLOQ) at all study visits where pharmacokinetic (PK) samples were collected.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.73', 'spread': '0.675', 'groupId': 'OG000'}, {'value': '58.53', 'spread': '0.589', 'groupId': 'OG001'}, {'value': '59.23', 'spread': '0.591', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 5', 'categories': [{'measurements': [{'value': '-4.78', 'spread': '0.828', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.724', 'groupId': 'OG001'}, {'value': '-1.72', 'spread': '0.724', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.31', 'ciLowerLimit': '2.19', 'ciUpperLimit': '6.43', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.078', 'groupDescription': 'ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.06', 'ciLowerLimit': '0.95', 'ciUpperLimit': '5.17', 'pValueComment': 'The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.072', 'groupDescription': 'ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.', 'statisticalMethod': 'ANCOVA with LOCF', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'FG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'FG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'FG003', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Significant Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 16 investigative sites in the United States from 21 November 2016 to 09 June 2017.', 'preAssignmentDetails': 'Healthy volunteers were randomized in a 1:1:1:1 ratio to one of 4 treatment arms: vortioxetine 10 mg, vortioxetine 20 mg, paroxetine or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.'}, {'id': 'BG001', 'title': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'BG002', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.'}, {'id': 'BG003', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '5.45', 'groupId': 'BG000'}, {'value': '28.9', 'spread': '5.96', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '5.56', 'groupId': 'BG002'}, {'value': '28.8', 'spread': '5.91', 'groupId': 'BG003'}, {'value': '28.4', 'spread': '5.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '185', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants.'}, {'title': 'Race/Ethnicity, 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{'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}]}, {'title': 'NA/Participant is male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '185', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants.'}, {'title': 'Duration of Menstruation', 'classes': [{'denoms': [{'units': 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Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-10', 'size': 932355, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-22T13:51', 'hasProtocol': True}, {'date': '2017-07-24', 'size': 1268070, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-22T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2016-10-12', 'resultsFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)', 'timeFrame': 'Baseline and Week 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4', 'timeFrame': 'Baseline and Weeks 1, 2, 3 and 4', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5', 'timeFrame': 'Weeks 1, 2, 3, 4 and 5', 'description': 'Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.'}, {'measure': 'Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}, {'measure': 'Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4 and 5', 'description': 'The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.', 'detailedDescription': 'The drug being tested in this study is called vortioxetine. This study will look at the effect of treatment on sexual functioning in healthy participants.\n\nThe study will enroll approximately 352 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):\n\n* Vortioxetine 10 mg\n* Vortioxetine 20 mg\n* Paroxetine 20 mg\n* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient\n\nAll participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.\n\nThis multicenter trial will be conducted in United States. The overall time to participate in this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.\n2. Has a body mass index (BMI) of 18 to 35 kg/m\\^2, inclusive, at the Screening and Baseline Visits.\n3. If female, has a regular menstrual cycle.\n4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score \\>47 (men) or \\>41 (women) at the Screening and Baseline Visits.\n5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.\n\nExclusion Criteria:\n\n1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.\n2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.\n3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.\n4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.\n5. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.\n6. Has a history of depression or any other psychiatric illness.\n7. Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.\n8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.\n9. Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).\n10. If female, has polycystic ovarian syndrome.\n11. Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.\n12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator."}, 'identificationModule': {'nctId': 'NCT02932904', 'briefTitle': 'Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group, Placebo- and Active-Controlled, Phase 4 Study Evaluating the Effect of Vortioxetine 10 and 20 mg/Day vs Paroxetine 20 mg/Day on Sexual Functioning in Healthy Subjects', 'orgStudyIdInfo': {'id': 'Vortioxetine-4001'}, 'secondaryIdInfos': [{'id': 'U1111-1174-1779', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.', 'interventionNames': ['Drug: Vortioxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.', 'interventionNames': ['Drug: Vortioxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paroxetine 20 mg', 'description': 'Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.', 'interventionNames': ['Drug: Paroxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'description': 'Vortioxetine Overencapsulated Tablet', 'armGroupLabels': ['Vortioxetine 10 mg', 'Vortioxetine 20 mg']}, {'name': 'Paroxetine', 'type': 'DRUG', 'description': 'Paroxetine Overencapsulated Tablets.', 'armGroupLabels': ['Paroxetine 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vortioxetine Placebo-matching Capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Encino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}