Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-03 @ 11:23 AM
Study NCT ID:
NCT00644358
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069503', 'term': 'Vilazodone Hydrochloride'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com', 'phone': '1-877-277-8566', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.', 'otherNumAtRisk': 599, 'otherNumAffected': 497, 'seriousNumAtRisk': 599, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 214}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 189}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 82}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 54}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 64}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 120}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 64}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 62}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 78}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Duodenal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Serotonin syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 599, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.'}, {'type': 'SECONDARY', 'title': 'Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.9', 'spread': '4.45', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '5.38', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-9.3', 'spread': '6.72', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 3', 'categories': [{'measurements': [{'value': '-13.0', 'spread': '7.76', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-14.9', 'spread': '7.99', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 6', 'categories': [{'measurements': [{'value': '-17.1', 'spread': '8.28', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-18.5', 'spread': '8.38', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-19.9', 'spread': '8.31', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 16', 'categories': [{'measurements': [{'value': '-20.6', 'spread': '8.31', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 20', 'categories': [{'measurements': [{'value': '-21.1', 'spread': '8.39', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 24', 'categories': [{'measurements': [{'value': '-21.7', 'spread': '7.81', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 28', 'categories': [{'measurements': [{'value': '-21.6', 'spread': '7.99', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 32', 'categories': [{'measurements': [{'value': '-21.9', 'spread': '8.26', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 36', 'categories': [{'measurements': [{'value': '-22.1', 'spread': '7.89', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 40', 'categories': [{'measurements': [{'value': '-22.7', 'spread': '7.33', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 44', 'categories': [{'measurements': [{'value': '-21.9', 'spread': '8.12', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 48', 'categories': [{'measurements': [{'value': '-22.5', 'spread': '7.92', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 52', 'categories': [{'measurements': [{'value': '-22.8', 'spread': '7.89', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Early Termination', 'categories': [{'measurements': [{'value': '-10.9', 'spread': '9.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': 'The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 3', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 6', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 16', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 20', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 24', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 28', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 32', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 36', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 40', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 44', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 48', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 52', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Early Termination', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': 'The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': "The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '616'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Consent Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'Lack of Effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Other Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '12.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '407', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '545', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '479', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.4', 'spread': '9.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 616}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2008-03-20', 'resultsFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-22', 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).'}], 'secondaryOutcomes': [{'measure': 'Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': 'The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.'}, {'measure': 'Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': 'The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination', 'description': "The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '24127687', 'type': 'DERIVED', 'citation': 'Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.'}, {'pmid': '23216998', 'type': 'DERIVED', 'citation': 'Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.'}, {'pmid': '22106941', 'type': 'DERIVED', 'citation': 'Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.'}, {'pmid': '21869687', 'type': 'DERIVED', 'citation': 'Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011 Oct;31(5):643-6. doi: 10.1097/JCP.0b013e31822c6741.'}]}, 'descriptionModule': {'briefSummary': 'This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.', 'detailedDescription': 'Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females 18-70 years of age.\n* Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.\n* Hamilton Depression Rating Scale (HAM-D) score ≥ 18 on the first 17 items of the 21-item HAM-D at Screening and Baseline Visits.\n* Patients must have general ocular health.\n\nExclusion Criteria:\n\n* Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).\n* Patients who meet DSM-IV-TR criteria for substance abuse or dependence within 1 year of the Baseline visit.\n* Patients who, in the Investigator's judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to Screening Visit.\n* Patients who are taking psychotropic drugs. Patients who have taken psychotropic drugs must have discontinued these prior to Screening Visit.\n* Patients taking migraine medications with a serotonergic mechanism of action.\n* Patients taking Cytochrome P450 3A4 (CYP3A4) inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics.\n* Patients with a known hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or 5-hydroxytryptamine 1a (5-HT1a) agonists.\n* Patients previously treated with vilazodone.\n* Patients taking Chantix or St. John's Wort.\n* Presence of significant acute or chronic medical disorders by history or physical exam.\n* Patients with a history of seizure disorders.\n* Prior history of malignancy if patient has \\<5 year survival OR completed treatment \\<1 year prior to enrollment and is currently without evidence of recurrence.\n* Skin cancers other than malignant melanoma will be permitted.\n* Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders.\n* Patients with renal impairment or hepatic impairment.\n* Patients who are not euthyroid.\n* Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication.\n* Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial.\n* Patients with clinically significant ECG abnormalities which, as determined by the investigator, make it unlikely that the patient would complete one year of treatment or would otherwise preclude treatment with vilazodone.\n* Patients having clinically significant abnormal laboratory findings.\n* Patients with a positive drug screen.\n* Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.\n* Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days."}, 'identificationModule': {'nctId': 'NCT00644358', 'briefTitle': 'A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'CLDA-07-DP-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vilazodone', 'description': 'Vilazodone titrated up to 40 mg/day for 1 year.', 'interventionNames': ['Drug: vilazodone']}], 'interventions': [{'name': 'vilazodone', 'type': 'DRUG', 'otherNames': ['EMD 68843, SB-659746'], 'description': 'titration to 40 milligrams (mg) every day (qd) for 1 year', 'armGroupLabels': ['Vilazodone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Affiliated Research 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