Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-28 @ 6:14 PM
Study NCT ID:
NCT01163266
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 157, 'otherNumAffected': 80, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 155, 'otherNumAffected': 103, 'seriousNumAtRisk': 155, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.', 'otherNumAtRisk': 150, 'otherNumAffected': 94, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.77', 'spread': '0.807', 'groupId': 'OG000'}, {'value': '-12.96', 'spread': '0.832', 'groupId': 'OG001'}, {'value': '-14.41', 'spread': '0.845', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.19', 'ciLowerLimit': '-4.45', 'ciUpperLimit': '0.08', 'pValueComment': 'Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.151', 'groupDescription': 'All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.64', 'ciLowerLimit': '-5.92', 'ciUpperLimit': '-1.35', 'pValueComment': 'Pre-specified sequential statistical testing procedure indicates that when p-value \\<0.025, hierarchical testing continues.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.161', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a MADRS Response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '33.8', 'groupId': 'OG001'}, {'value': '39.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.301', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.290', 'ciLowerLimit': '0.796', 'ciUpperLimit': '2.093', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with explanatory variables for treatment and Baseline MADRS score.', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.639', 'ciLowerLimit': '1.013', 'ciUpperLimit': '2.652', 'pValueComment': 'Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with explanatory variables for treatment and Baseline MADRS score.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward was used.'}, {'type': 'SECONDARY', 'title': 'Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '0.094', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8', 'description': "The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.26', 'spread': '1.392', 'groupId': 'OG000'}, {'value': '-14.55', 'spread': '1.369', 'groupId': 'OG001'}, {'value': '-17.52', 'spread': '1.331', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-8.03', 'ciUpperLimit': '-0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.891', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.26', 'ciLowerLimit': '-10.92', 'ciUpperLimit': '-3.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.852', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.\n\nThe HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in MADRS Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '22.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.665', 'ciLowerLimit': '0.918', 'ciUpperLimit': '3.018', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with explanatory variables for treatment and Baseline MADRS score.', 'testedNonInferiority': False}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.779', 'ciLowerLimit': '0.979', 'ciUpperLimit': '3.233', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with explanatory variables for treatment and Baseline MADRS score.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.86', 'spread': '0.771', 'groupId': 'OG000'}, {'value': '-7.25', 'spread': '0.747', 'groupId': 'OG001'}, {'value': '-8.26', 'spread': '0.794', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-3.44', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.042', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.', 'testedNonInferiority': False}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-4.50', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.066', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'FG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'FG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event or Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 37 investigative sites in the United States from 15 July 2010 to 17 January 2012.', 'preAssignmentDetails': 'Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups, once a day placebo, 10 mg, or 20 mg vortioxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '462', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.'}, {'id': 'BG001', 'title': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.'}, {'id': 'BG002', 'title': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '11.61', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '12.04', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '13.09', 'groupId': 'BG002'}, {'value': '42.8', 'spread': '12.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≤55 years', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}]}, {'title': '>55 years', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic and non-Latino', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '425', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian (White, including Hispanic)', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '462', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '167.46', 'spread': '9.265', 'groupId': 'BG000'}, {'value': '166.86', 'spread': '9.199', 'groupId': 'BG001'}, {'value': '167.92', 'spread': '9.194', 'groupId': 'BG002'}, {'value': '167.41', 'spread': '9.210', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '88.28', 'spread': '23.290', 'groupId': 'BG000'}, {'value': '89.00', 'spread': '23.076', 'groupId': 'BG001'}, {'value': '87.08', 'spread': '23.582', 'groupId': 'BG002'}, {'value': '88.13', 'spread': '23.277', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.31', 'spread': '7.262', 'groupId': 'BG000'}, {'value': '31.92', 'spread': '7.779', 'groupId': 'BG001'}, {'value': '30.84', 'spread': '7.836', 'groupId': 'BG002'}, {'value': '31.36', 'spread': '7.622', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '100.20', 'spread': '18.640', 'groupId': 'BG000'}, {'value': '99.76', 'spread': '16.996', 'groupId': 'BG001'}, {'value': '96.76', 'spread': '16.434', 'groupId': 'BG002'}, {'value': '98.93', 'spread': '17.426', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}]}, {'title': 'Once monthly or less often', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}]}, {'title': 'Once per week', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': '2-to-6 times per week', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Daily', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Montgomery Åsberg Depression Rating Scale (MADRS) total score', 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '3.99', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '4.52', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '4.30', 'groupId': 'BG002'}, {'value': '32.2', 'spread': '4.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Anxiety Scale Total Score', 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '5.41', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '5.25', 'groupId': 'BG001'}, {'value': '18.9', 'spread': '5.64', 'groupId': 'BG002'}, {'value': '18.4', 'spread': '5.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (absent) to 56 (maximum severity).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression - Severity scale score', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.55', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '0.55', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '0.54', 'groupId': 'BG002'}, {'value': '4.5', 'spread': '0.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-25', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-25', 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline and Week 8', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a MADRS Response at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.'}, {'measure': 'Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8', 'timeFrame': 'Week 8', 'description': "The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects."}, {'measure': 'Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20', 'timeFrame': 'Baseline and Week 8', 'description': 'The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.\n\nThe HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.'}, {'measure': 'Percentage of Participants in MADRS Remission at Week 8', 'timeFrame': 'Week 8', 'description': 'Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.'}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Depression', 'Melancholia', 'Drug Therapy'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '36708956', 'type': 'DERIVED', 'citation': 'Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.'}, {'pmid': '31818787', 'type': 'DERIVED', 'citation': 'Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.'}, {'pmid': '26035185', 'type': 'DERIVED', 'citation': 'Jacobsen PL, Mahableshwarkar AR, Serenko M, Chan S, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder. J Clin Psychiatry. 2015 May;76(5):575-82. doi: 10.4088/JCP.14m09335.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.', 'detailedDescription': 'The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.\n\nThe study enrolled 462 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):\n\n* Vortioxetine 10 mg\n* Vortioxetine 20 mg\n* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.\n\nAll participants were asked to take one capsule at the same time each day throughout the study.\n\nThis multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 9 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.\n* Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.\n* Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* Has previously participated in a Lu AA21004 clinical study.\n* Has 1 or more the following:\n\n * Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV\n * Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.\n * Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).\n * Presence or history of a clinically significant neurological disorder (including epilepsy)\n * Neurodegenerative disorder.\n * Any Axis II disorder that might compromise the study.\n* Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.\n* Has clinically significant abnormal vital signs as determined by the investigator.\n* Has an abnormal Electrocardiogram.\n* Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n* Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.\n* Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.\n* Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.\n* Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.\n* Has a significant risk of suicide according to the investigator's opinion."}, 'identificationModule': {'nctId': 'NCT01163266', 'briefTitle': 'Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LuAA21004_316'}, 'secondaryIdInfos': [{'id': 'U1111-1115-8770', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 8 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 10 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.', 'interventionNames': ['Drug: Vortioxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 20 mg', 'description': 'Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.', 'interventionNames': ['Drug: Vortioxetine']}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'otherNames': ['Lu AA21004', 'Brintellix®'], 'description': 'Encapsulated vortioxetine immediate release tablets', 'armGroupLabels': ['Vortioxetine 10 mg', 'Vortioxetine 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vortioxetine placebo-matching capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': 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{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Brown Deer', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.16334, 'lon': -87.96453}}], 'overallOfficials': [{'name': 'Medical Director, Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}