{"protocolSection":{"identificationModule":{"nctId":"NCT00811252","orgStudyIdInfo":{"id":"12541A"},"secondaryIdInfos":[{"id":"2008-002901-38","type":"EUDRACT_NUMBER"},{"id":"2008","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2008"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients","officialTitle":"Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients"},"statusModule":{"statusVerifiedDate":"2013-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-01"},"primaryCompletionDateStruct":{"date":"2010-02","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03","type":"ACTUAL"},"studyFirstSubmitDate":"2008-12-17","studyFirstSubmitQcDate":"2008-12-17","studyFirstPostDateStruct":{"date":"2008-12-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-28","resultsFirstSubmitQcDate":"2013-10-28","resultsFirstPostDateStruct":{"date":"2013-12-18","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-12-23","lastUpdatePostDateStruct":{"date":"2014-01-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depression","Elderly","Acute treatment"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":453,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Vortioxetine 5 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]},{"label":"Duloxetine 60 mg","type":"OTHER","description":"Active reference","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"capsules; daily; orally","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"encapsulated tablets; daily; orally","armGroupLabels":["Vortioxetine 5 mg"],"otherNames":["Brintellix"]},{"type":"DRUG","name":"Duloxetine","description":"encapsulated tablets; daily; orally","armGroupLabels":["Duloxetine 60 mg"],"otherNames":["Cymbalta®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment","description":"The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. 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The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","timeFrame":"Baseline and Week 8"},{"measure":"Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment","description":"The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.","timeFrame":"Baseline and Week 8"},{"measure":"Change From Baseline in CGI-S Score After 8 Weeks of Treatment","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.","timeFrame":"Baseline and Week 8"},{"measure":"Change in Clinical Status Using CGI-I Score at Week 8","description":"The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.","timeFrame":"Week 8"},{"measure":"Change From Baseline in GDS Total Score After 8 Weeks of Treatment","description":"The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.","timeFrame":"Baseline and Week 8"},{"measure":"Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)","timeFrame":"Week 8"},{"measure":"Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)","timeFrame":"Week 8"},{"measure":"Risk of Suicidality Using C-SSRS Scores","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.","timeFrame":"Up to 8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nClinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:\n\n* Reported duration of the current episode of at least 4 weeks\n* MADRS total score \\>=26\n* At least one previous MDE before the age of 60 years\n\nExclusion Criteria:\n\n* Mini Mental State Exam (MMSE) \\<24\n* Any current anxiety disorder as defined in the DSM-IV-TR\n* Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR\n* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR\n* Presence or history of a clinically significant neurological disorder (including epilepsy)\n* Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)\n* Any Axis II disorder that might compromise the study\n* Significant risk of suicide according to the investigator's opinion, or has a score \\>=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months\n\nOther 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"}]},"referencesModule":{"references":[{"pmid":"22572889","type":"RESULT","citation":"Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).","recruitmentDetails":"Patients were mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient settings.","groups":[{"id":"FG000","title":"Placebo","description":"capsules; daily; orally"},{"id":"FG001","title":"Vortioxetine 5 mg","description":"encapsulated tablets; daily; orally"},{"id":"FG002","title":"Duloxetine 60 mg","description":"encapsulated tablets; daily; orally"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"145"},{"groupId":"FG001","numSubjects":"156"},{"groupId":"FG002","numSubjects":"151"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"128"},{"groupId":"FG001","numSubjects":"136"},{"groupId":"FG002","numSubjects":"128"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"23"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Administrative or Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable","groups":[{"id":"BG000","title":"Placebo","description":"capsules; daily; orally"},{"id":"BG001","title":"Vortioxetine 5 mg","description":"encapsulated tablets; daily; orally"},{"id":"BG002","title":"Duloxetine 60 mg","description":"encapsulated tablets; daily; orally"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"145"},{"groupId":"BG001","value":"156"},{"groupId":"BG002","value":"151"},{"groupId":"BG003","value":"452"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"70.3","spread":"4.4"},{"groupId":"BG001","value":"70.5","spread":"4.8"},{"groupId":"BG002","value":"70.9","spread":"5.5"},{"groupId":"BG003","value":"70.6","spread":"4.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"107"},{"groupId":"BG002","value":"100"},{"groupId":"BG003","value":"297"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"155"}]}]}]},{"title":"HAM-D-24","description":"The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. 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The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.5","spread":"5.7"},{"groupId":"BG001","value":"19.9","spread":"5.8"},{"groupId":"BG002","value":"19.2","spread":"6.5"},{"groupId":"BG003","value":"19.5","spread":"6.0"}]}]}]},{"title":"CGI-S","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). 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