[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100120829":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":44,"centralContacts":11,"locations":11,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":11},{"fullName":5,"class":6},"H. Lundbeck A\u002FS","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR",null,[13],"Drug: Placebo",{"label":15,"type":16,"description":11,"interventionNames":17},"Vortioxetine (Lu AA21004) 5 mg","EXPERIMENTAL",[18],"Drug: Vortioxetine (Lu AA21004)",{"label":20,"type":16,"description":11,"interventionNames":21},"Vortioxetine (Lu AA21004) 10 mg",[18],{"label":23,"type":24,"description":25,"interventionNames":26},"Venlafaxine XL 225 mg","OTHER","Active Reference",[27],"Drug: Venlafaxine XL",[29,33,39],{"type":30,"name":9,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","capsules, daily, orally",[9],{"type":30,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Vortioxetine (Lu AA21004)","encapsulated tablets, daily, orally",[20,15],[38],"Brintellix",{"type":30,"name":40,"description":31,"armGroupLabels":41,"otherNames":42},"Venlafaxine XL",[23],[43],"Effexor®",[45],{"name":46,"affiliation":47,"role":48},"Email contact via H. Lundbeck A\u002FS","LundbeckClinicalTrials@lundbeck.com","STUDY_DIRECTOR",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100120829","phase-2-randomised-placebo-controlled-venlafaxine-referenced-study-of-efficacy-and-safety-of-5-and-10-mg-of-vortioxetine-lu-aa21004-in-acute-treatment-of-major-depressive-disorder-in-adults-100120829",true,"NCT00839423","Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults","Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder","Inclusion Criteria:\n\n* MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)\n* Current MDE duration of at least 3 months and less than 12 months\n* The patient has a MADRS total score \\>=30\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR\n* Any substance disorder within the previous 6 months\n* Female patients of childbearing potential who are not using effective contraception\n* Use of any psychoactive medication 2 weeks prior to screening and during the study\n\nOther protocol-defined inclusion and exclusion criteria may apply.",false,"ALL","18 Years","65 Years",{"count":63,"type":64},426,"ACTUAL","INTERVENTIONAL",[67],"PHASE2","The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).",[70],"Major Depressive Disorder",[72,73,74,75,76,77],"Major depressive disorder","Placebo-controlled","Active reference","Multicenter study","Randomised study","Acute treatment","COMPLETED","2014-04-22",{"date":81,"type":82},"2014-05-13","ESTIMATED",{"date":84,"type":11},"2006-08",{"date":86,"type":64},"2007-09",{"name":5,"class":6}]