Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03560518
Status:
TERMINATED
Last Update Posted:
2020-09-01
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Rapastinel as Monotherapy in Patients With MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507283', 'term': 'GLYX-13 peptide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, '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}, 'limitationsAndCaveats': {'description': 'Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.'}}, 'adverseEventsModule': {'timeFrame': 'The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period.', 'description': 'The Safety Population consists of all randomized patients who received at least 1 dose of randomized IP.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo (prefilled syringe, weekly IV administration)', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 15, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Rapastinel 450mg', 'description': 'Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 28, 'seriousNumAtRisk': 145, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Rapastinel 900mg', 'description': 'Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 21, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (prefilled syringe, weekly IV administration)'}, {'id': 'OG001', 'title': 'Rapastinel 450mg', 'description': 'Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)'}, {'id': 'OG002', 'title': 'Rapastinel 900mg', 'description': 'Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.8', 'spread': '11.93', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '11.62', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '11.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of Week 6', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (mITT) Population will consist of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (prefilled syringe, weekly IV administration)'}, {'id': 'OG001', 'title': 'Rapastinel 450mg', 'description': 'Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)'}, {'id': 'OG002', 'title': 'Rapastinel 900mg', 'description': 'Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '9.18', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '8.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 1 post-first dose', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (mITT) Population will consist of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo (prefilled syringe, weekly IV administration)'}, {'id': 'FG001', 'title': 'Rapastinel 450mg', 'description': 'Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)'}, {'id': 'FG002', 'title': 'Rapastinel 900mg', 'description': 'Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)'}], 'periods': [{'title': 'Double Blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Terminated by the Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Safety Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '437', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo (prefilled syringe, weekly IV administration)'}, {'id': 'BG001', 'title': 'Rapastinel 450mg', 'description': 'Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)'}, {'id': 'BG002', 'title': 'Rapastinel 900mg', 'description': 'Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '14.35', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '14.02', 'groupId': 'BG001'}, {'value': '44.5', 'spread': '13.14', 'groupId': 'BG002'}, {'value': '44.7', 'spread': '13.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '361', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', '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': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '86.42', 'spread': '18.11', 'groupId': 'BG000'}, {'value': '88.20', 'spread': '18.61', 'groupId': 'BG001'}, {'value': '85.33', 'spread': '20.71', 'groupId': 'BG002'}, {'value': '86.64', 'spread': '19.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.41', 'spread': '9.66', 'groupId': 'BG000'}, {'value': '168.75', 'spread': '9.83', 'groupId': 'BG001'}, {'value': '168.57', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '168.58', 'spread': '9.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.54', 'spread': '6.39', 'groupId': 'BG000'}, {'value': '30.96', 'spread': '6.13', 'groupId': 'BG001'}, {'value': '30.00', 'spread': '6.96', 'groupId': 'BG002'}, {'value': '30.50', 'spread': '6.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montgomery-Asberg Depression Rating Scale (MADRS) total score at baseline', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '4.50', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '4.71', 'groupId': 'BG001'}, {'value': '35.9', 'spread': '4.69', 'groupId': 'BG002'}, {'value': '35.5', 'spread': '4.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The modified Intent-to-Treat (mITT) Population will consist of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 509597, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-07T19:09', 'hasProtocol': False}, {'date': '2018-04-10', 'size': 713312, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-07T19:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'whyStopped': 'Business decision to stop the program.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-15', 'studyFirstSubmitDate': '2018-06-07', 'resultsFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-15', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)', 'timeFrame': 'Baseline to end of Week 6', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment', 'timeFrame': 'Baseline to Day 1 post-first dose', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD\n* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1\n* Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode\n* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test\n\nExclusion Criteria:\n\n* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1\n* Lifetime history of meeting DSM-5 criteria for:\n* Schizophrenia spectrum or other psychotic disorder\n* Bipolar or related disorder\n* Major neurocognitive disorder\n* Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study\n* Dissociative disorder\n* Posttraumatic stress disorder\n* MDD with psychotic features\n* Significant suicide risk, as judged by the Investigator"}, 'identificationModule': {'nctId': 'NCT03560518', 'briefTitle': 'Study of Rapastinel as Monotherapy in Patients With MDD', 'organization': {'class': 'INDUSTRY', 'fullName': 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