Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 7:47 AM
Study NCT ID:
NCT01878292
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2013-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
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': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': "All data generated in this study are the property of the sponsor. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the sponsor and will follow sponsor's standard operating procedures on publications.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 63, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 81, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 97, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration'}, {'id': 'OG001', 'title': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration'}, {'id': 'OG002', 'title': 'Vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.48', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '-22.94', 'spread': '0.904', 'groupId': 'OG001'}, {'value': '-24.22', 'spread': '0.872', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to week 8', 'description': "The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score."}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions-Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration'}, {'id': 'OG001', 'title': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration'}, {'id': 'OG002', 'title': 'Vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '0.089', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': "The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration'}, {'id': 'FG001', 'title': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration'}, {'id': 'FG002', 'title': 'Vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration'}], 'periods': [{'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}, {'title': 'Double-blind Down-Taper Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '526', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration'}, {'id': 'BG001', 'title': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration'}, {'id': 'BG002', 'title': 'Vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '14.8', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '313', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '464', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '71.87', 'spread': '20.78', 'groupId': 'BG000'}, {'value': '70.10', 'spread': '20.65', 'groupId': 'BG001'}, {'value': '70.89', 'spread': '20.58', 'groupId': 'BG002'}, {'value': '70.95', 'spread': '20.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.97', 'spread': '7.15', 'groupId': 'BG000'}, {'value': '25.30', 'spread': '6.86', 'groupId': 'BG001'}, {'value': '25.66', 'spread': '6.70', 'groupId': 'BG002'}, {'value': '25.64', 'spread': '6.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 529}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2013-06-11', 'resultsFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-06', 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score", 'timeFrame': 'From Baseline to week 8', 'description': "The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood."}], 'secondaryOutcomes': [{'measure': 'Change in Clinical Global Impressions-Severity (CGI-S) Score', 'timeFrame': 'From Baseline to Week 8', 'description': "The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '29633166', 'type': 'DERIVED', 'citation': 'Durgam S, Chen C, Migliore R, Prakash C, Edwards J, Findling RL. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder. Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female outpatients between 12-17 years of age\n* Primary diagnosis of major depressive disorder (MDD)\n* Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater\n* Clinical Global Impressions-Severity (CGI-S) score of 4 or greater\n\nExclusion Criteria:\n\n* Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.\n* History of suicidal behavior, or requires precaution against suicide\n* Not generally healthy medical condition\n* Seizure disorder"}, 'identificationModule': {'nctId': 'NCT01878292', 'acronym': 'VLZ-MD-21', 'briefTitle': 'Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'VLZ-MD-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dose-matched placebo tablets, once per day, oral administration', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vilazodone 15 mg', 'description': '15 mg vilazodone tablets, once per day, oral administration', 'interventionNames': ['Drug: Vilazodone']}, {'type': 'EXPERIMENTAL', 'label': 'vilazodone 30 mg', 'description': '30 mg vilazodone tablets, once per day, oral administration', 'interventionNames': ['Drug: Vilazodone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose matched placebo tablets, once per day, oral administration.', 'armGroupLabels': ['Placebo']}, {'name': 'Vilazodone', 'type': 'DRUG', 'otherNames': ['Viibryd'], 'description': 'Vilazodone tablets, 15 mg per day, oral administration', 'armGroupLabels': ['Vilazodone 15 mg']}, {'name': 'Vilazodone', 'type': 'DRUG', 'otherNames': ['Viibryd'], 'description': 'Vilazodone tablets, 30 mg once per day, oral administration', 'armGroupLabels': ['vilazodone 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 073', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}, {'zip': '90027', 'city': 'Los Angeles', 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