{"protocolSection":{"identificationModule":{"nctId":"NCT02400346","orgStudyIdInfo":{"id":"16160A"},"secondaryIdInfos":[{"id":"2014-003547-35","type":"EUDRACT_NUMBER"},{"id":"2014","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2014"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment","officialTitle":"Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment"},"statusModule":{"statusVerifiedDate":"2017-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-03"},"primaryCompletionDateStruct":{"date":"2016-06","type":"ACTUAL"},"completionDateStruct":{"date":"2016-06","type":"ACTUAL"},"studyFirstSubmitDate":"2015-03-17","studyFirstSubmitQcDate":"2015-03-23","studyFirstPostDateStruct":{"date":"2015-03-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-06-02","resultsFirstSubmitQcDate":"2017-06-02","resultsFirstPostDateStruct":{"date":"2017-06-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-07-11","lastUpdatePostDateStruct":{"date":"2017-08-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment"},"conditionsModule":{"conditions":["Major Depression Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":132,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Adjunct brexpiprazole","type":"EXPERIMENTAL","description":"All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition","interventionNames":["Drug: Adjunct brexpiprazole","Drug: ADT"]}],"interventions":[{"type":"DRUG","name":"Adjunct brexpiprazole","description":"Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.\n\nTablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.","armGroupLabels":["Adjunct brexpiprazole"]},{"type":"DRUG","name":"ADT","description":"Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label","armGroupLabels":["Adjunct brexpiprazole"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Patients With Treatment-Emergent Adverse Events","description":"Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit","timeFrame":"Baseline to 30 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Main Inclusion Criteria:\n\n* • The patient is a man or woman aged ≥65 yrs\n\n  * The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).\n  * The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE).\n  * The patient has had the current MDE for ≥8 weeks\n  * The patient is currently treated with a protocol specified ADT for at least 6 weeks\n  * The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.\n  * Montgomery and Åsberg Depression Rating Scale (MADRS) total score \\> 18 at screening and baseline\n  * Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline\n\nMain Exclusion Criteria:\n\n* • The patient has a clinically significant unstable illness\n\n  * The patient has newly diagnosed or unstable diabetes\n  * The patient has a Mini Mental State Exam (MMSE) score \\<24\n  * The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening.\n  * The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide\n\nOther protocol defined inclusion and exclusion criteria may apply","healthyVolunteers":false,"sex":"ALL","minimumAge":"65 Years","stdAges":["OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Email contact via H. Lundbeck A/S","affiliation":"LundbeckClinicalTrials@Lundbeck.com","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"US012","city":"Arcadia","state":"California","country":"United States","geoPoint":{"lat":34.13973,"lon":-118.03534}},{"facility":"US004","city":"Miami","state":"Florida","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"US007","city":"Orlando","state":"Florida","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"US006","city":"Smyrna","state":"Georgia","country":"United States","geoPoint":{"lat":33.88399,"lon":-84.51438}},{"facility":"US002","city":"O'Fallon","state":"Missouri","country":"United States","geoPoint":{"lat":38.81061,"lon":-90.69985}},{"facility":"US010","city":"Toms River","state":"New Jersey","country":"United States","geoPoint":{"lat":39.95373,"lon":-74.19792}},{"facility":"US005","city":"New York","state":"New York","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"US008","city":"New York","state":"New York","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"US003","city":"Staten Island","state":"New York","country":"United States","geoPoint":{"lat":40.56233,"lon":-74.13986}},{"facility":"US014","city":"Oklahoma City","state":"Oklahoma","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"US009","city":"Allentown","state":"Pennsylvania","country":"United States","geoPoint":{"lat":40.60843,"lon":-75.49018}},{"facility":"US001","city":"Memphis","state":"Tennessee","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"US011","city":"San Antonio","state":"Texas","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"EE002","city":"Tallinn","country":"Estonia","geoPoint":{"lat":59.43696,"lon":24.75353}},{"facility":"EE001","city":"Tartu","country":"Estonia","geoPoint":{"lat":58.38062,"lon":26.72509}},{"facility":"EE004","city":"Tartu","country":"Estonia","geoPoint":{"lat":58.38062,"lon":26.72509}},{"facility":"EE003","city":"Võru","country":"Estonia","geoPoint":{"lat":57.83389,"lon":27.01944}},{"facility":"FI001","city":"Helsinki","country":"Finland","geoPoint":{"lat":60.16952,"lon":24.93545}},{"facility":"FI002","city":"Kuopio","country":"Finland","geoPoint":{"lat":62.89238,"lon":27.67703}},{"facility":"FI003","city":"Oulu","country":"Finland","geoPoint":{"lat":65.01236,"lon":25.46816}},{"facility":"FI004","city":"Tampere","country":"Finland","geoPoint":{"lat":61.49911,"lon":23.78712}},{"facility":"DE002","city":"Berlin","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"DE008","city":"Berlin","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"DE003","city":"Frankfurt","country":"Germany","geoPoint":{"lat":49.68333,"lon":10.53333}},{"facility":"DE007","city":"Hanover","country":"Germany","geoPoint":{"lat":52.37052,"lon":9.73322}},{"facility":"DE006","city":"Mittweida","country":"Germany","geoPoint":{"lat":50.98622,"lon":12.97537}},{"facility":"DE001","city":"Schwerin","country":"Germany","geoPoint":{"lat":53.62937,"lon":11.41316}},{"facility":"DE005","city":"Wiesbaden","country":"Germany","geoPoint":{"lat":50.08601,"lon":8.24435}},{"facility":"PL006","city":"Bialystok","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"PL003","city":"Bydgoszcz","country":"Poland","geoPoint":{"lat":53.1235,"lon":18.00762}},{"facility":"PL001","city":"Chełmno","country":"Poland","geoPoint":{"lat":53.34855,"lon":18.4251}},{"facility":"PL005","city":"Gdansk","country":"Poland","geoPoint":{"lat":54.35227,"lon":18.64912}},{"facility":"PL004","city":"Lublin","country":"Poland","geoPoint":{"lat":51.25058,"lon":22.57009}},{"facility":"PL002","city":"Pruszcz Gdański","country":"Poland","geoPoint":{"lat":54.26217,"lon":18.63625}}]},"referencesModule":{"references":[{"pmid":"30039634","type":"DERIVED","citation":"Lepola U, Hefting N, Zhang D, Hobart M. Adjunctive brexpiprazole for elderly patients with major depressive disorder: An open-label, long-term safety and tolerability study. Int J Geriatr Psychiatry. 2018 Oct;33(10):1403-1410. doi: 10.1002/gps.4952. Epub 2018 Jul 23."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Adjunct Brexpiprazole","description":"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.\n\nAdjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.\n\nTablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"132"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"88"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"9"}]},{"type":"Non-compliance with IMP","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"Administrative or other reason(s)","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Adjunct Brexpiprazole","description":"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.\n\nAdjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.\n\nTablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"71.4","spread":"5.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"107"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"25"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"130"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"52"}]}]},{"title":"Finland","categories":[{"measurements":[{"groupId":"BG000","value":"27"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"15"}]}]},{"title":"Estonia","categories":[{"measurements":[{"groupId":"BG000","value":"21"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Patients With Treatment-Emergent Adverse Events","description":"Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline to 30 weeks","groups":[{"id":"OG000","title":"Adjunct Brexpiprazole","description":"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.\n\nAdjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.\n\nTablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"102"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline to end of study (30 weeks)","description":"Treatment-Emergent Adverse Events are reported in this section","eventGroups":[{"id":"EG000","title":"Brex + ADT","deathsNumAffected":1,"deathsNumAtRisk":132,"seriousNumAffected":6,"seriousNumAtRisk":132,"otherNumAffected":79,"otherNumAtRisk":132}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Myocardial rupture","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Postoperative wound infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Eye contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Facial bones fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Panic attack","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132}]},{"term":"Hypotension","organSystem":"Vascular 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19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":132}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132}]},{"term":"Restlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":132}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Email contact via","organization":"H. 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