[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alto Neuroscience\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,66,89],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100635511","phase-2-alto-207-in-adults-with-treatment-resistant-depression-trd-100635511",false,"NCT07553637","ALTO-207 in Adults With Treatment-resistant Depression (TRD)","A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression","Inclusion Criteria:\n\n* Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.\n* Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).\n* Failure to respond (\\\u003C50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)\n* Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline\n\nExclusion Criteria:\n\n* Evidence of unstable medical condition\n* Concurrent use of any prohibited medications or substance use disorder\n* Diagnosed bipolar disorder or a psychotic disorder or symptoms\n* Significant current PTSD symptoms or history of PTSD\n* Clinically significant current impulse control difficulties\n* Has a history of hypersensitivity or allergic reaction to ALTO-207 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","75 Years",{"count":20,"type":21},178,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.",[27],"Treatment-resistant Depression (TRD)","RECRUITING","2026-04-23",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":21},"2026-05",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Alto Neuroscience","INDUSTRY",48,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100554736","phase-2-study-of-alto-101-in-patients-with-schizophrenia-100554736","NCT06502964","Study of ALTO-101 in Patients With Schizophrenia","Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment","Inclusion Criteria:\n\n* Schizophrenia diagnosis for at least one year\n* Cognitive impairment\n* Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2\n* Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening\n* Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg\u002Fm2 (inclusive)\n* Willing to comply with all study assessments and procedures\n\nExclusion Criteria:\n\n* Evidence of unstable medical condition\n* Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months\n* Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability\n* Current episode of major depressive disorder (MDD)\n* Use of mood stabilizer, clozapine, and\u002For daily benzodiazepine\n* Current moderate or severe substance use disorder","21 Years","55 Years",{"count":51,"type":21},82,[24],"This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.\n\nAdditional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.",[55,56],"Schizophrenia","Cognitive Impairment","2025-12-23",{"date":59,"type":32},"2025-12-26",{"date":61,"type":32},"2024-06-11",{"date":63,"type":21},"2026-03",{"name":38,"class":39},14,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100510164","phase-2-study-of-alto-300-in-mdd-100510164","NCT05922878","Study of ALTO-300 in MDD","A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Have a diagnosis of moderate to severe major depressive disorder (MDD)\n* At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2\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* Nightly use of sleep medication\n* Diagnosed bipolar disorder, psychotic disorder, or dementia\n* Current moderate or severe substance use disorder\n* Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components\u002Fexcipients\n* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device","70 Years",{"count":75,"type":21},321,[24],"The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.",[79],"Major Depressive Disorder","2025-07-21",{"date":82,"type":32},"2025-07-24",{"date":84,"type":32},"2023-06-08",{"date":86,"type":21},"2026-12",{"name":38,"class":39},45,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100566533","phase-2-alto-100-in-bipolar-disorder-with-depression-bd-d-100566533","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",{"count":97,"type":21},200,[24],"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.",[101],"Bipolar Disorder I or II With a Major Depressive Episode",[103,104,105],"Bipolar I","Bipolar II","Major Depressive Episode","2025-07-11",{"date":108,"type":32},"2025-07-16",{"date":110,"type":32},"2024-10-02",{"date":112,"type":21},"2026-10",{"name":38,"class":39},27,""]