[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibni617\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibni617":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Major Depressive Disorder (MDD)","IBNI617","NOT_YET_RECRUITING","2026-07-29",{"date":32,"type":33},"2026-07-30","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2028-04",{"name":39,"class":40},"IBIOME BIOTECHNOLOGY CO., LTD","INDUSTRY"]