[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100068621":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":30,"locations":30,"responsibleParty":36,"collaborators":30,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":30,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":30,"enrollmentInfo":48,"targetDuration":30,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":30,"overallStatus":57,"whyStopped":30,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":30},{"fullName":5,"class":6},"Organon and Co","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Asenapine","EXPERIMENTAL","Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.",[13],"Drug: Asenapine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.",[9],[26],"Org 5222",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo fast dissolving SL tablets, BID",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Medical Director","Merck Sharp & Dohme LLC","STUDY_DIRECTOR",{"type":37,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100068621","phase-3-12-week-study-of-the-safetyefficacy-of-asenapine-when-added-to-lithiumvalproate-in-the-treatment-of-bipolar-disorder-a7501008--p05844--mk-8274-017-100068621",true,"NCT00145470","12 Week Study of the Safety\u002FEfficacy of Asenapine When Added to Lithium\u002FValproate in the Treatment of Bipolar Disorder (A7501008 \u002F P05844 \u002F MK-8274-017)","A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid\u002FDivalproex Sodium for the Treatment of an Acute Manic or Mixed Episode","Inclusion Criteria:\n\n* Have bipolar I disorder, current episode manic or mixed\n* Treated with lithium or valproic acid\n\nExclusion Criteria:\n\n* Have an unstable medical condition\n* Clinically significant laboratory abnormality.\n* Have a primary diagnosis other than bipolar I disorder.",false,"ALL","18 Years",{"count":49,"type":50},326,"ACTUAL","INTERVENTIONAL",[53],"PHASE3","This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.",[56],"Bipolar Disorder","COMPLETED","2024-05-08",{"date":60,"type":50},"2024-05-21",{"date":62,"type":50},"2005-06-02",{"date":64,"type":50},"2007-03-22",{"name":5,"class":6}]