[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-i-or-ii-with-a-major-depressive-episode\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-i-or-ii-with-a-major-depressive-episode":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100566533",false,"NCT06656416","ALTO-100 in Bipolar Disorder With Depression (BD-D)","A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode","Inclusion Criteria:\n\n* Have a diagnosis of BD-I or BD-II as well as BD-D\n* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and\u002For taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, and asenapine) for at least 6 weeks with no dose modifications in the past 2 weeks\n* Willing to comply with all study assessments and procedures\n* Must not be pregnant or breastfeeding at time of enrollment or throughout study\n\nExclusion Criteria:\n\n* Evidence of unstable medical condition\n* Concurrent use of any prohibited medications or substance use disorder\n* Diagnosed psychotic disorder (other than mania or depression)\n* Current moderate or severe substance use disorder\n* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components\u002Fexcipients\n* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device","ALL","18 Years","70 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and\u002For atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.",[26],"Bipolar Disorder I or II With a Major Depressive Episode",[28,29,30],"Bipolar I","Bipolar II","Major Depressive Episode","RECRUITING","2025-07-11",{"date":34,"type":35},"2025-07-16","ACTUAL",{"date":37,"type":35},"2024-10-02",{"date":39,"type":20},"2026-10",{"name":41,"class":42},"Alto Neuroscience","INDUSTRY",27,""]