[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318280":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Korea Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Abilify (Tablet)","EXPERIMENTAL",null,[13],"Drug: Abilify 2, 5, 10, 15mg (Tablet)",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo of Abilify (Tablet)","PLACEBO_COMPARATOR",[18],"Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Abilify 2, 5, 10, 15mg (Tablet)","Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Placebo of Abilify 2, 5, 10, 15mg (Tablet)",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Hoyoung Lee","CONTACT","82-2-3287-9238","hoyounglee@otsuka.co.kr",[35],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":11,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Seounl National University Hospital","RECRUITING","Seoul","South Korea",{"type":41,"coordinates":42},"Point",[43,44],126.9784,37.566,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":11,"phoneExt":11,"email":11},"Yong Min Ahn, MD PhD",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100318280","phase-3-a-study-of-abilify-tabletaripiprazole-as-an-adjunctive-treatment-in-the-bipolar-depression-100318280",false,"NCT03423680","A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression","A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder","APOLLO","Inclusion Criteria:\n\n* Patients aged ≥ 19 and \\\u003C 70 years at the time of informed consent\n* Patients who are able to understand information required for providing a consent\n* Patients who have received a mood stabilizer (lithium or valproic acid)\n* Patients with bipolar I or II disorder accompanied by major depressive episode\n* Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits\n\nExclusion Criteria:\n\n* Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features\n* Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history","ALL","19 Years","70 Years",{"count":63,"type":64},390,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.\n\nThis study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.",[70],"Depression, Bipolar","2024-08-16",{"date":73,"type":74},"2024-08-19","ACTUAL",{"date":76,"type":74},"2018-02-22",{"date":78,"type":64},"2025-12",{"name":5,"class":6},1]