[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053451":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":267,"collaborators":30,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":271,"sex":277,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":30,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":290,"overallStatus":61,"whyStopped":30,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"ACADIA Pharmaceuticals Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ACP-211 600 mg","EXPERIMENTAL","ACP-211 600 mg, administered orally twice weekly",[13],"Drug: ACP-211",{"label":15,"type":10,"description":16,"interventionNames":17},"ACP-211 300 mg","ACP-211 300 mg, administered orally twice weekly",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Matching placebo, administered orally twice weekly",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","ACP-211","ACP-211 monotherapy",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo control",[19],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Sandy Filosi","CONTACT","+1(609) 250-6920","sfilosi@ACADIA-Pharm.com",{"name":41,"role":37,"phone":42,"phoneExt":30,"email":43},"Lori Lykens","+1(609) 250-6917","lori.lykens@acadia-pharm.com",[45,59,70,79,88,97,107,117,126,135,144,153,163,173,183,193,203,213,223,233,243,249,258],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":30},"University of Alabama at Birmingham","ACTIVE_NOT_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.80249,33.52066,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":30},"Inland Psychiatric Medical Group","RECRUITING","Chino","California","91710",{"type":54,"coordinates":66},[67,68],-117.68894,34.01223,{"lat":68,"lon":67},{"facility":71,"status":61,"city":72,"state":63,"zip":73,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":30},"Behavioral Research Specialists, LLC","Glendale","91107",{"type":54,"coordinates":75},[76,77],-118.25508,34.14251,{"lat":77,"lon":76},{"facility":80,"status":61,"city":81,"state":63,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":30},"Kadima Neuropsychiatry Institute","La Jolla","92037",{"type":54,"coordinates":84},[85,86],-117.2742,32.84727,{"lat":86,"lon":85},{"facility":89,"status":61,"city":90,"state":63,"zip":91,"country":51,"countryCode":52,"cosmosGeoPoint":92,"geoPoint":96,"contacts":30},"PNS Clinical Research LLC dba ATP Clinical Research","Orange","92866",{"type":54,"coordinates":93},[94,95],-117.85311,33.78779,{"lat":95,"lon":94},{"facility":98,"status":61,"city":99,"state":100,"zip":101,"country":51,"countryCode":52,"cosmosGeoPoint":102,"geoPoint":106,"contacts":30},"Mountain View Clinical Research","Denver","Colorado","80209",{"type":54,"coordinates":103},[104,105],-104.9847,39.73915,{"lat":105,"lon":104},{"facility":108,"status":61,"city":109,"state":110,"zip":111,"country":51,"countryCode":52,"cosmosGeoPoint":112,"geoPoint":116,"contacts":30},"The Medici Medical Research","Hollywood","Florida","33021",{"type":54,"coordinates":113},[114,115],-80.14949,26.0112,{"lat":115,"lon":114},{"facility":118,"status":47,"city":119,"state":110,"zip":120,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":30},"Sandhill Research, LLC\u002FDBA Accel Research Sites","Largo","33777",{"type":54,"coordinates":122},[123,124],-82.78842,27.90979,{"lat":124,"lon":123},{"facility":127,"status":61,"city":128,"state":110,"zip":129,"country":51,"countryCode":52,"cosmosGeoPoint":130,"geoPoint":134,"contacts":30},"Clinical Neuroscience Solutions, Inc.","Orlando","32801",{"type":54,"coordinates":131},[132,133],-81.37924,28.53834,{"lat":133,"lon":132},{"facility":136,"status":61,"city":137,"state":110,"zip":138,"country":51,"countryCode":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":30},"IPTB Clinical Research","Tampa","33629",{"type":54,"coordinates":140},[141,142],-82.45843,27.94752,{"lat":142,"lon":141},{"facility":145,"status":61,"city":146,"state":110,"zip":147,"country":51,"countryCode":52,"cosmosGeoPoint":148,"geoPoint":152,"contacts":30},"Neuroscience Research Institute, Inc.","West Palm Beach","33407",{"type":54,"coordinates":149},[150,151],-80.05337,26.71534,{"lat":151,"lon":150},{"facility":154,"status":61,"city":155,"state":156,"zip":157,"country":51,"countryCode":52,"cosmosGeoPoint":158,"geoPoint":162,"contacts":30},"Vitalix Clinical, Inc.","Worcester","Massachusetts","01608",{"type":54,"coordinates":159},[160,161],-71.80229,42.26259,{"lat":161,"lon":160},{"facility":164,"status":61,"city":165,"state":166,"zip":167,"country":51,"countryCode":52,"cosmosGeoPoint":168,"geoPoint":172,"contacts":30},"Precise Research Centers","Flowood","Mississippi","39232",{"type":54,"coordinates":169},[170,171],-90.13898,32.30959,{"lat":171,"lon":170},{"facility":174,"status":61,"city":175,"state":176,"zip":177,"country":51,"countryCode":52,"cosmosGeoPoint":178,"geoPoint":182,"contacts":30},"St. Charles Psychiatric Associates, Inc. dba Midwest Research Group","Saint Charles","Missouri","63304",{"type":54,"coordinates":179},[180,181],-90.48123,38.78394,{"lat":181,"lon":180},{"facility":184,"status":61,"city":185,"state":186,"zip":187,"country":51,"countryCode":52,"cosmosGeoPoint":188,"geoPoint":192,"contacts":30},"Redbird Research LLC","Las Vegas","Nevada","89134",{"type":54,"coordinates":189},[190,191],-115.13722,36.17497,{"lat":191,"lon":190},{"facility":194,"status":47,"city":195,"state":196,"zip":197,"country":51,"countryCode":52,"cosmosGeoPoint":198,"geoPoint":202,"contacts":30},"CenExel Hassman Research Institute, LLC","Marlton","New Jersey","08053",{"type":54,"coordinates":199},[200,201],-74.92183,39.89122,{"lat":201,"lon":200},{"facility":204,"status":61,"city":205,"state":206,"zip":207,"country":51,"countryCode":52,"cosmosGeoPoint":208,"geoPoint":212,"contacts":30},"Integrative Clinical Trials LLC","Brooklyn","New York","11229",{"type":54,"coordinates":209},[210,211],-73.94958,40.6501,{"lat":211,"lon":210},{"facility":214,"status":61,"city":215,"state":216,"zip":217,"country":51,"countryCode":52,"cosmosGeoPoint":218,"geoPoint":222,"contacts":30},"Magnolia Clinical Research, LLC","Cary","North Carolina","27511",{"type":54,"coordinates":219},[220,221],-78.78112,35.79154,{"lat":221,"lon":220},{"facility":224,"status":61,"city":225,"state":226,"zip":227,"country":51,"countryCode":52,"cosmosGeoPoint":228,"geoPoint":232,"contacts":30},"Neuro-Behavioral Clinical Research","North Canton","Ohio","44720",{"type":54,"coordinates":229},[230,231],-81.40234,40.87589,{"lat":231,"lon":230},{"facility":234,"status":61,"city":235,"state":236,"zip":237,"country":51,"countryCode":52,"cosmosGeoPoint":238,"geoPoint":242,"contacts":30},"Baylor College of Medicine","Houston","Texas","77030",{"type":54,"coordinates":239},[240,241],-95.36327,29.76328,{"lat":241,"lon":240},{"facility":244,"status":47,"city":235,"state":236,"zip":245,"country":51,"countryCode":52,"cosmosGeoPoint":246,"geoPoint":248,"contacts":30},"Dynamed Clinical Research LP d\u002Fb\u002Fa DM Clinical Research","77081",{"type":54,"coordinates":247},[240,241],{"lat":241,"lon":240},{"facility":250,"status":61,"city":251,"state":236,"zip":252,"country":51,"countryCode":52,"cosmosGeoPoint":253,"geoPoint":257,"contacts":30},"Olympus Clinical Research, LLC","Katy","77450",{"type":54,"coordinates":254},[255,256],-95.8244,29.78579,{"lat":256,"lon":255},{"facility":259,"status":61,"city":260,"state":236,"zip":261,"country":51,"countryCode":52,"cosmosGeoPoint":262,"geoPoint":266,"contacts":30},"Family Psychiatry of The Woodlands","The Woodlands","77381",{"type":54,"coordinates":263},[264,265],-95.48938,30.15799,{"lat":265,"lon":264},{"type":268,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":281,"type":282},153,"ESTIMATED","INTERVENTIONAL",[285],"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?",[288,289],"Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant",[288,289,291,292,293,294,295,296],"Antidepressive Agents","Randomized Controlled Trial","Double-Blind Method","Clinical Trial, Phase II","Psychiatric Status Rating Scales","Ketamine","2026-07-10",{"date":299,"type":300},"2026-07-13","ACTUAL",{"date":302,"type":300},"2025-11-14",{"date":304,"type":282},"2027-09",{"name":5,"class":6},23]