[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608049":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":544,"collaborators":29,"id":546,"slug":547,"hasResults":548,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":29,"eligibilityCriteria":552,"healthyVolunteers":548,"sex":553,"minAge":554,"maxAge":29,"enrollmentInfo":555,"targetDuration":29,"studyType":558,"phases":559,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":575},{"fullName":5,"class":6},"Neurocrine Biosciences","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label Treatment Period: NBI-1065845","EXPERIMENTAL","Participants will be treated with NBI-1065845 during the open-label treatment period.",[13],"Drug: NBI-1065845",{"label":15,"type":10,"description":16,"interventionNames":17},"Randomized Double-blind Maintenance Period: NBI-1065845","Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Randomized Double-blind Maintenance Period: Placebo","Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.",[22],"Drug: Placebo",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","NBI-1065845","Oral tablet",[9,15],null,{"type":25,"name":31,"description":27,"armGroupLabels":32,"otherNames":29},"Placebo",[19],[34],{"name":35,"affiliation":5,"role":36},"Clinical Development Lead","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":29,"email":42},"Neurocrine Medical Information Call Center","CONTACT","1-877-641-3461","medinfo@neurocrine.com",[44,58,66,74,83,92,100,108,116,125,134,143,152,161,170,179,187,196,206,214,223,231,239,248,257,268,276,284,294,299,304,309,320,329,338,347,355,365,370,378,389,397,404,412,422,430,438,448,456,464,474,482,487,492,503,511,516,526,534,539],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":29},"Neurocrine Clinical Site","RECRUITING","Oceanside","California","92056","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.37948,33.19587,{"lat":56,"lon":55},{"facility":45,"status":46,"city":59,"state":48,"zip":60,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":65,"contacts":29},"Orange","92868",{"type":53,"coordinates":62},[63,64],-117.85311,33.78779,{"lat":64,"lon":63},{"facility":45,"status":46,"city":67,"state":48,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":29},"San Jose","95124",{"type":53,"coordinates":70},[71,72],-121.89496,37.33939,{"lat":72,"lon":71},{"facility":45,"status":46,"city":75,"state":76,"zip":77,"country":50,"countryCode":51,"cosmosGeoPoint":78,"geoPoint":82,"contacts":29},"New Haven","Connecticut","06520",{"type":53,"coordinates":79},[80,81],-72.92816,41.30815,{"lat":81,"lon":80},{"facility":45,"status":46,"city":84,"state":85,"zip":86,"country":50,"countryCode":51,"cosmosGeoPoint":87,"geoPoint":91,"contacts":29},"Miami Gardens","Florida","33014",{"type":53,"coordinates":88},[89,90],-80.2456,25.94204,{"lat":90,"lon":89},{"facility":45,"status":46,"city":93,"state":85,"zip":94,"country":50,"countryCode":51,"cosmosGeoPoint":95,"geoPoint":99,"contacts":29},"Orlando","32803",{"type":53,"coordinates":96},[97,98],-81.37924,28.53834,{"lat":98,"lon":97},{"facility":45,"status":46,"city":101,"state":85,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":29},"Palm Bay","32905",{"type":53,"coordinates":104},[105,106],-80.58866,28.03446,{"lat":106,"lon":105},{"facility":45,"status":46,"city":109,"state":85,"zip":110,"country":50,"countryCode":51,"cosmosGeoPoint":111,"geoPoint":115,"contacts":29},"Tampa","33629",{"type":53,"coordinates":112},[113,114],-82.45843,27.94752,{"lat":114,"lon":113},{"facility":45,"status":46,"city":117,"state":118,"zip":119,"country":50,"countryCode":51,"cosmosGeoPoint":120,"geoPoint":124,"contacts":29},"Iowa City","Iowa","52242",{"type":53,"coordinates":121},[122,123],-91.53017,41.66113,{"lat":123,"lon":122},{"facility":45,"status":46,"city":126,"state":127,"zip":128,"country":50,"countryCode":51,"cosmosGeoPoint":129,"geoPoint":133,"contacts":29},"Marrero","Louisiana","70072",{"type":53,"coordinates":130},[131,132],-90.10035,29.89937,{"lat":132,"lon":131},{"facility":45,"status":46,"city":135,"state":136,"zip":137,"country":50,"countryCode":51,"cosmosGeoPoint":138,"geoPoint":142,"contacts":29},"O'Fallon","Missouri","63368",{"type":53,"coordinates":139},[140,141],-90.69985,38.81061,{"lat":141,"lon":140},{"facility":45,"status":46,"city":144,"state":145,"zip":146,"country":50,"countryCode":51,"cosmosGeoPoint":147,"geoPoint":151,"contacts":29},"Albuquerque","New Mexico","87109",{"type":53,"coordinates":148},[149,150],-106.65114,35.08449,{"lat":150,"lon":149},{"facility":45,"status":46,"city":153,"state":154,"zip":155,"country":50,"countryCode":51,"cosmosGeoPoint":156,"geoPoint":160,"contacts":29},"Glen Oaks","New York","11004",{"type":53,"coordinates":157},[158,159],-73.71152,40.74705,{"lat":159,"lon":158},{"facility":45,"status":46,"city":162,"state":163,"zip":164,"country":50,"countryCode":51,"cosmosGeoPoint":165,"geoPoint":169,"contacts":29},"Charlotte","North Carolina","28211",{"type":53,"coordinates":166},[167,168],-80.84313,35.22709,{"lat":168,"lon":167},{"facility":45,"status":46,"city":171,"state":172,"zip":173,"country":50,"countryCode":51,"cosmosGeoPoint":174,"geoPoint":178,"contacts":29},"Edmond","Oklahoma","73013",{"type":53,"coordinates":175},[176,177],-97.4781,35.65283,{"lat":177,"lon":176},{"facility":45,"status":46,"city":180,"state":172,"zip":181,"country":50,"countryCode":51,"cosmosGeoPoint":182,"geoPoint":186,"contacts":29},"Oklahoma City","73112",{"type":53,"coordinates":183},[184,185],-97.51643,35.46756,{"lat":185,"lon":184},{"facility":45,"status":46,"city":188,"state":189,"zip":190,"country":50,"countryCode":51,"cosmosGeoPoint":191,"geoPoint":195,"contacts":29},"Philadelphia","Pennsylvania","19104",{"type":53,"coordinates":192},[193,194],-75.16362,39.95238,{"lat":194,"lon":193},{"facility":45,"status":197,"city":198,"state":199,"zip":200,"country":50,"countryCode":51,"cosmosGeoPoint":201,"geoPoint":205,"contacts":29},"ACTIVE_NOT_RECRUITING","Austin","Texas","78712",{"type":53,"coordinates":202},[203,204],-97.74306,30.26715,{"lat":204,"lon":203},{"facility":45,"status":46,"city":207,"state":199,"zip":208,"country":50,"countryCode":51,"cosmosGeoPoint":209,"geoPoint":213,"contacts":29},"Bellaire","77401",{"type":53,"coordinates":210},[211,212],-95.45883,29.70579,{"lat":212,"lon":211},{"facility":45,"status":215,"city":216,"state":199,"zip":217,"country":50,"countryCode":51,"cosmosGeoPoint":218,"geoPoint":222,"contacts":29},"TERMINATED","Friendswood","77546",{"type":53,"coordinates":219},[220,221],-95.20104,29.5294,{"lat":221,"lon":220},{"facility":45,"status":46,"city":224,"state":199,"zip":225,"country":50,"countryCode":51,"cosmosGeoPoint":226,"geoPoint":230,"contacts":29},"Stafford","77477",{"type":53,"coordinates":227},[228,229],-95.55772,29.61607,{"lat":229,"lon":228},{"facility":45,"status":46,"city":232,"state":199,"zip":233,"country":50,"countryCode":51,"cosmosGeoPoint":234,"geoPoint":238,"contacts":29},"Wichita Falls","76309",{"type":53,"coordinates":235},[236,237],-98.49339,33.91371,{"lat":237,"lon":236},{"facility":45,"status":46,"city":240,"state":241,"zip":242,"country":50,"countryCode":51,"cosmosGeoPoint":243,"geoPoint":247,"contacts":29},"Draper","Utah","84020",{"type":53,"coordinates":244},[245,246],-111.86382,40.52467,{"lat":246,"lon":245},{"facility":45,"status":46,"city":249,"state":250,"zip":251,"country":50,"countryCode":51,"cosmosGeoPoint":252,"geoPoint":256,"contacts":29},"Roanoke","Virginia","24018",{"type":53,"coordinates":253},[254,255],-79.94143,37.27097,{"lat":255,"lon":254},{"facility":45,"status":46,"city":258,"state":259,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":29},"Carlton","Victoria","3053","Australia","AU",{"type":53,"coordinates":264},[265,266],144.96667,-37.8,{"lat":266,"lon":265},{"facility":45,"status":46,"city":269,"state":259,"zip":270,"country":261,"countryCode":262,"cosmosGeoPoint":271,"geoPoint":275,"contacts":29},"Melbourne","3004",{"type":53,"coordinates":272},[273,274],144.96332,-37.814,{"lat":274,"lon":273},{"facility":45,"status":46,"city":277,"state":259,"zip":278,"country":261,"countryCode":262,"cosmosGeoPoint":279,"geoPoint":283,"contacts":29},"Parkville","3050",{"type":53,"coordinates":280},[281,282],144.95,-37.78333,{"lat":282,"lon":281},{"facility":45,"status":46,"city":285,"state":29,"zip":286,"country":287,"countryCode":288,"cosmosGeoPoint":289,"geoPoint":293,"contacts":29},"Sofia","1303","Bulgaria","BG",{"type":53,"coordinates":290},[291,292],23.32415,42.69751,{"lat":292,"lon":291},{"facility":45,"status":46,"city":285,"state":29,"zip":295,"country":287,"countryCode":288,"cosmosGeoPoint":296,"geoPoint":298,"contacts":29},"1408",{"type":53,"coordinates":297},[291,292],{"lat":292,"lon":291},{"facility":45,"status":46,"city":285,"state":29,"zip":300,"country":287,"countryCode":288,"cosmosGeoPoint":301,"geoPoint":303,"contacts":29},"1510",{"type":53,"coordinates":302},[291,292],{"lat":292,"lon":291},{"facility":45,"status":46,"city":285,"state":29,"zip":305,"country":287,"countryCode":288,"cosmosGeoPoint":306,"geoPoint":308,"contacts":29},"1680",{"type":53,"coordinates":307},[291,292],{"lat":292,"lon":291},{"facility":45,"status":46,"city":310,"state":311,"zip":312,"country":313,"countryCode":314,"cosmosGeoPoint":315,"geoPoint":319,"contacts":29},"Calgary","Alberta","T2N 2T9","Canada","CA",{"type":53,"coordinates":316},[317,318],-114.08529,51.05011,{"lat":318,"lon":317},{"facility":45,"status":46,"city":321,"state":322,"zip":323,"country":313,"countryCode":314,"cosmosGeoPoint":324,"geoPoint":328,"contacts":29},"North Vancouver","British Columbia","V7P 2T4",{"type":53,"coordinates":325},[326,327],-123.06934,49.31636,{"lat":327,"lon":326},{"facility":45,"status":46,"city":330,"state":331,"zip":332,"country":313,"countryCode":314,"cosmosGeoPoint":333,"geoPoint":337,"contacts":29},"Kingston","Ontario","K7L 4X3",{"type":53,"coordinates":334},[335,336],-76.48098,44.22976,{"lat":336,"lon":335},{"facility":45,"status":46,"city":339,"state":340,"zip":341,"country":313,"countryCode":314,"cosmosGeoPoint":342,"geoPoint":346,"contacts":29},"Sherbrooke","Quebec","J1L 0H8",{"type":53,"coordinates":343},[344,345],-71.89908,45.40008,{"lat":345,"lon":344},{"facility":45,"status":46,"city":348,"state":29,"zip":349,"country":313,"countryCode":314,"cosmosGeoPoint":350,"geoPoint":354,"contacts":29},"Toronto","M5H 1A1",{"type":53,"coordinates":351},[352,353],-79.39864,43.70643,{"lat":353,"lon":352},{"facility":45,"status":46,"city":356,"state":29,"zip":357,"country":358,"countryCode":359,"cosmosGeoPoint":360,"geoPoint":364,"contacts":29},"Tallinn","10138","Estonia","EE",{"type":53,"coordinates":361},[362,363],24.75353,59.43696,{"lat":363,"lon":362},{"facility":45,"status":46,"city":356,"state":29,"zip":366,"country":358,"countryCode":359,"cosmosGeoPoint":367,"geoPoint":369,"contacts":29},"11315",{"type":53,"coordinates":368},[362,363],{"lat":363,"lon":362},{"facility":45,"status":46,"city":371,"state":29,"zip":372,"country":358,"countryCode":359,"cosmosGeoPoint":373,"geoPoint":377,"contacts":29},"Tartu","50417",{"type":53,"coordinates":374},[375,376],26.72509,58.38062,{"lat":376,"lon":375},{"facility":45,"status":379,"city":380,"state":29,"zip":381,"country":382,"countryCode":383,"cosmosGeoPoint":384,"geoPoint":388,"contacts":29},"WITHDRAWN","Milan","20127","Italy","IT",{"type":53,"coordinates":385},[386,387],12.59836,42.78235,{"lat":387,"lon":386},{"facility":45,"status":46,"city":390,"state":29,"zip":391,"country":382,"countryCode":383,"cosmosGeoPoint":392,"geoPoint":396,"contacts":29},"Roma","168",{"type":53,"coordinates":393},[394,395],11.10642,44.99364,{"lat":395,"lon":394},{"facility":45,"status":46,"city":398,"state":29,"zip":391,"country":382,"countryCode":383,"cosmosGeoPoint":399,"geoPoint":403,"contacts":29},"Rome",{"type":53,"coordinates":400},[401,402],12.51133,41.89193,{"lat":402,"lon":401},{"facility":45,"status":46,"city":405,"state":29,"zip":406,"country":382,"countryCode":383,"cosmosGeoPoint":407,"geoPoint":411,"contacts":29},"Torino","10126",{"type":53,"coordinates":408},[409,410],11.99138,44.88856,{"lat":410,"lon":409},{"facility":45,"status":46,"city":413,"state":29,"zip":414,"country":415,"countryCode":416,"cosmosGeoPoint":417,"geoPoint":421,"contacts":29},"Bialystok","15-879","Poland","PL",{"type":53,"coordinates":418},[419,420],23.16433,53.13333,{"lat":420,"lon":419},{"facility":45,"status":46,"city":423,"state":29,"zip":424,"country":415,"countryCode":416,"cosmosGeoPoint":425,"geoPoint":429,"contacts":29},"Bydgoszcz","85-794",{"type":53,"coordinates":426},[427,428],18.00762,53.1235,{"lat":428,"lon":427},{"facility":45,"status":46,"city":431,"state":29,"zip":432,"country":415,"countryCode":416,"cosmosGeoPoint":433,"geoPoint":437,"contacts":29},"Gdansk","80-283",{"type":53,"coordinates":434},[435,436],18.64912,54.35227,{"lat":436,"lon":435},{"facility":45,"status":46,"city":439,"state":29,"zip":440,"country":441,"countryCode":442,"cosmosGeoPoint":443,"geoPoint":447,"contacts":29},"Belgrade","11000","Serbia","RS",{"type":53,"coordinates":444},[445,446],20.46513,44.80401,{"lat":446,"lon":445},{"facility":45,"status":46,"city":449,"state":29,"zip":450,"country":441,"countryCode":442,"cosmosGeoPoint":451,"geoPoint":455,"contacts":29},"Kovin","26220",{"type":53,"coordinates":452},[453,454],20.97611,44.7475,{"lat":454,"lon":453},{"facility":45,"status":46,"city":457,"state":29,"zip":458,"country":441,"countryCode":442,"cosmosGeoPoint":459,"geoPoint":463,"contacts":29},"Kragujevac","34000",{"type":53,"coordinates":460},[461,462],20.91667,44.01667,{"lat":462,"lon":461},{"facility":45,"status":46,"city":465,"state":466,"zip":467,"country":468,"countryCode":29,"cosmosGeoPoint":469,"geoPoint":473,"contacts":29},"Ansan-si","Gyeonggi-do","15355","South Korea",{"type":53,"coordinates":470},[471,472],126.82194,37.32361,{"lat":472,"lon":471},{"facility":45,"status":46,"city":475,"state":29,"zip":476,"country":468,"countryCode":29,"cosmosGeoPoint":477,"geoPoint":481,"contacts":29},"Seoul","02841",{"type":53,"coordinates":478},[479,480],126.9784,37.566,{"lat":480,"lon":479},{"facility":45,"status":46,"city":475,"state":29,"zip":483,"country":468,"countryCode":29,"cosmosGeoPoint":484,"geoPoint":486,"contacts":29},"06351",{"type":53,"coordinates":485},[479,480],{"lat":480,"lon":479},{"facility":45,"status":46,"city":475,"state":29,"zip":488,"country":468,"countryCode":29,"cosmosGeoPoint":489,"geoPoint":491,"contacts":29},"3181",{"type":53,"coordinates":490},[479,480],{"lat":480,"lon":479},{"facility":45,"status":46,"city":493,"state":494,"zip":495,"country":496,"countryCode":497,"cosmosGeoPoint":498,"geoPoint":502,"contacts":29},"Alcorcón","Madrid","28922","Spain","ES",{"type":53,"coordinates":499},[500,501],-3.82487,40.34582,{"lat":501,"lon":500},{"facility":45,"status":46,"city":504,"state":29,"zip":505,"country":496,"countryCode":497,"cosmosGeoPoint":506,"geoPoint":510,"contacts":29},"Barcelona","08025",{"type":53,"coordinates":507},[508,509],2.15899,41.38879,{"lat":509,"lon":508},{"facility":45,"status":46,"city":504,"state":29,"zip":512,"country":496,"countryCode":497,"cosmosGeoPoint":513,"geoPoint":515,"contacts":29},"08035",{"type":53,"coordinates":514},[508,509],{"lat":509,"lon":508},{"facility":45,"status":46,"city":517,"state":29,"zip":518,"country":519,"countryCode":520,"cosmosGeoPoint":521,"geoPoint":525,"contacts":29},"Keelung","204","Taiwan","TW",{"type":53,"coordinates":522},[523,524],121.74094,25.13089,{"lat":524,"lon":523},{"facility":45,"status":46,"city":527,"state":29,"zip":528,"country":519,"countryCode":520,"cosmosGeoPoint":529,"geoPoint":533,"contacts":29},"Taipei","10449",{"type":53,"coordinates":530},[531,532],121.52639,25.05306,{"lat":532,"lon":531},{"facility":45,"status":46,"city":527,"state":29,"zip":535,"country":519,"countryCode":520,"cosmosGeoPoint":536,"geoPoint":538,"contacts":29},"110",{"type":53,"coordinates":537},[531,532],{"lat":532,"lon":531},{"facility":45,"status":46,"city":527,"state":29,"zip":540,"country":519,"countryCode":520,"cosmosGeoPoint":541,"geoPoint":543,"contacts":29},"11217",{"type":53,"coordinates":542},[531,532],{"lat":532,"lon":531},{"type":545,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100608049","phase-3-a-study-to-evaluate-the-maintenance-effect-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100608049",false,"NCT07196501","A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.\n* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).\n* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.\n\nKey Exclusion Criteria:\n\n* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":556,"type":557},550,"ESTIMATED","INTERVENTIONAL",[560],"PHASE3","The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.",[563],"Major Depressive Disorder",[563,565,26],"MDD","2026-07-22",{"date":568,"type":569},"2026-07-24","ACTUAL",{"date":571,"type":569},"2025-08-18",{"date":573,"type":557},"2028-07",{"name":5,"class":6},60]