[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ACADIA Pharmaceuticals Inc.\",\"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,[8,50,74,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053451","phase-2-acp-211-monotherapy-for-major-depressive-disorder-with-inadequate-antidepressant-response-100053451",false,"NCT07284667","ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response","A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment","NORLIGHT","Inclusion Criteria:\n\n* Adults ≥18 and ≤65 years of age\n* Provides written informed consent\n* Clinical diagnosis of MDD\n* History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode\n* Currently treated with an approved antidepressant at a stable dose prior to Screening\n* MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline\n* Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation\n\nExclusion Criteria:\n\n* Current diagnosis of certain personality disorders or persistent depressive disorder\n* Recent substance use disorders, excluding caffeine or nicotine\n* Active suicidal risk or recent suicidal attempt\n* History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features\n* Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD\n* History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)\n* Documented non-response to ADT, including ketamine or esketamine\n* Allergy or sensitivity to ketamine or esketamine\n* Significant cardiovascular disease\n* Positive history of hepatitis B, hepatitis C, or HIV infection\n* Unstable diabetes or uncontrolled medical conditions\n* Positive urine drug test for an illicit drug or cannabis\n* Received neuromodulation therapies (ECT,TMS, VNS, DBS) in the current depressive episode\n* Recent initiation or change in psychotherapy Additional inclusion\u002Fexclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.","ALL","18 Years","65 Years",{"count":21,"type":22},153,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).\n\nThe main questions the study aims to answer are:\n\n* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?\n* What adverse events do participants have when taking ACP-211?",[28,29],"Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant",[28,29,31,32,33,34,35,36],"Antidepressive Agents","Randomized Controlled Trial","Double-Blind Method","Clinical Trial, Phase II","Psychiatric Status Rating Scales","Ketamine","RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2025-11-14",{"date":45,"type":22},"2027-09",{"name":47,"class":48},"ACADIA Pharmaceuticals Inc.","INDUSTRY",23,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100595217","phase-2-phase-2-efficacy-and-safety-study-of-acp-204-in-lewy-body-dementia-psychosis-100595217","NCT07029581","Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis","A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)","Inclusion Criteria:\n\n* Male or female ≥55 years to \\\u003C85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting\n* Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:\n\n  1. The subject's LAR must provide written informed consent.\n  2. The subject must provide written (if capable) informed assent per local regulations.\n* Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association\n\nExclusion Criteria:\n\n* Is in hospice, is receiving end-of-life palliative care, or is bedridden\n* Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia\n* Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)\n* Has a history or current evidence of a serious and\u002For significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures\n* Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT","55 Years","84 Years",{"count":60,"type":22},180,[25],"Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.",[64],"Lewy Body Dementia Psychosis","2026-06-26",{"date":67,"type":41},"2026-06-30",{"date":69,"type":41},"2025-08-06",{"date":71,"type":22},"2028-03",{"name":47,"class":48},57,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100528354","phase-2-acp-204-in-adults-with-alzheimers-disease-psychosis-100528354","NCT06159673","ACP-204 in Adults With Alzheimer's Disease Psychosis","A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis","Inclusion Criteria:\n\n* Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting\n* Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)\n* Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD\n* Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD\n* Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association\n* MMSE score ≥6 and ≤24\n* Psychotic symptoms for at least 2 months\n* Lives in a stable place of residence and there are no plans to change living arrangements\n* Has a designated study partner\u002Fcaregiver\n* Able to complete all study visits with a study partner\u002Fcaregiver\n* Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable\n\nExclusion Criteria:\n\n* Requires treatment with a medication prohibited by the protocol\n* Is in hospice and receiving end-of-life palliative care, or has become bedridden\n* Requires skilled nursing care\n* Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia\n* Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope\n* Atrial fibrillation\n* Symptomatic orthostatic hypotension\n* Protocol-defined exclusionary clinical laboratory findings\n* Treatment with anti-tau therapy or donanemab within 2 months prior to Screening\n\nAdditional inclusion\u002Fexclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.","95 Years",{"count":83,"type":22},1074,[25,85],"PHASE3","This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP\n\n* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.\n* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.\n\nAll 3 substudies will be analyzed independently of each other.\n\nEach substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).",[88],"Alzheimer's Disease Psychosis",[90,91,92],"Alzheimer's disease psychosis","Hallucinations","Delusions","2026-06-15",{"date":95,"type":41},"2026-06-16",{"date":97,"type":41},"2023-11-14",{"date":99,"type":22},"2028-02",{"name":47,"class":48},145,{"id":103,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":26,"conditions":106,"keywords":107,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":113,"locationsCount":114},"100614828",{"count":21,"type":22},[25],[28,29],[28,29,31,32,33,34,35,36],"2026-06-05",{"date":110,"type":41},"2026-06-08",{"date":43,"type":41},{"date":45,"type":22},{"name":47,"class":48},21,""]