[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649009":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"IBIOME BIOTECHNOLOGY CO., LTD","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IBNI617","EXPERIMENTAL","IBNI617 BID for 8 weeks",[13],"Other: Live biotherapeutic product",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo BID for 8 weeks",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Live biotherapeutic product","IBNI617 PO BID",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo PO BID",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Huafang LI","CONTACT","+86 18017311256","hlhl_5@163.com",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Shen HE","+86 18817314682","shenhe0204@126.com",[41],{"facility":42,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shanghai Mental Health Center","Shanghai","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100649009","probiotic-ibni617-for-moderate-to-severe-depression-100649009",false,"NCT07728253","Probiotic IBNI617 for Moderate to Severe Depression","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Efficacy and Safety of Probiotic IBNI617 Enteric-Coated Capsules in Patients With Moderate to Severe Depression","Inclusion Criteria:\n\n* Meets DSM-5 criteria for a single episode or recurrent episode;\n* HAM-D-17 ≥ 22, total score of HAM-D-17 items 4, 5, and 6 ≥ 3;\n* MADRS ≥ 20, CGI-S ≥ 4;\n* Absence of antidepressant medication use or discontinuation of antidepressant medication prior to screening.\n\nExclusion Criteria:\n\n* Treatment-resistant depression;\n* Suicide attempt or suicide behavior within the past 6 months;\n* Used antibiotics within the past 2 weeks;\n* Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks;\n* With medical history or surgical history that may affect probiotic colonization.","ALL","18 Years","65 Years",{"count":67,"type":68},148,"ESTIMATED","INTERVENTIONAL",[71],"NA","IBNI617 is a live biotherapeutic product(LBP). This is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial to evaluate the efficacy and safety of IBNI617 in adult patients with major depressive disorder (MDD).\n\nEligible participants will be randomized in a 1:1 ratio to receive either IBNI617 or matched placebo twice daily for 8 weeks.\n\nThe primary objective is to assess the efficacy of IBNI617 compared with placebo, as measured by the change from baseline in HAM-D-17 total score at Week 8.",[74,9],"Major Depressive Disorder (MDD)","NOT_YET_RECRUITING","2026-07-29",{"date":78,"type":79},"2026-07-30","ACTUAL",{"date":81,"type":68},"2026-08",{"date":83,"type":68},"2028-04",{"name":5,"class":6},1]