[{"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":27},{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100566533","phase-2-alto-100-in-bipolar-disorder-with-depression-bd-d-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":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Bipolar Disorder I or II With a Major Depressive Episode",[29,30,31],"Bipolar I","Bipolar II","Major Depressive Episode","RECRUITING","2025-07-11",{"date":35,"type":36},"2025-07-16","ACTUAL",{"date":38,"type":36},"2024-10-02",{"date":40,"type":21},"2026-10",{"name":42,"class":43},"Alto Neuroscience","INDUSTRY",27]