[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575676":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":25,"studyPopulation":25,"armGroups":38,"interventions":50,"overallOfficials":25,"centralContacts":60,"locations":66,"responsibleParty":487,"collaborators":25,"id":489,"slug":25,"hasResults":490,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":490,"sex":496,"minAge":497,"maxAge":498,"enrollmentInfo":499,"targetDuration":25,"studyType":502,"phases":503,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},{"fullName":5,"class":6},"Xenon Pharmaceuticals Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6","The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.","Baseline to Week 6",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6","The SHAPS is a 14-item self-report questionnaire used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater anhedonia. A total score can be derived by summing the responses to each item. Items answered with \"strongly agree\" are assigned a score of 1, while \"strongly disagree\" responses are assigned a score of 4 points. Total scores on the SHAPS can range from 14 to 56 points, with higher scores corresponding to higher levels of anhedonia.",{"measure":18,"description":11,"timeFrame":19},"Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1","Baseline to Week 1",{"measure":21,"description":22,"timeFrame":12},"Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6","The CGI-S is a clinician-rated global measure of participant overall disease severity. Participants are rated on a 7-point severity scale, with higher scores indicating more severe depression.",{"measure":24,"description":25,"timeFrame":26},"To assess the safety and tolerability of azetukalner (e.g., adverse events)",null,"From screening (approximately 4 weeks prior to baseline) through to 8 weeks post-final dose.",{"allocation":28,"interventionModel":29,"interventionModelDescription":25,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Azetukalner","EXPERIMENTAL","Azetukalner 20 mg",[44],"Drug: Azetukalner",{"label":46,"type":47,"description":46,"interventionNames":48},"Placebo","PLACEBO_COMPARATOR",[49],"Drug: Placebo",[51,57],{"type":52,"name":40,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks",[40],[56],"XEN1101",{"type":52,"name":46,"description":58,"armGroupLabels":59,"otherNames":25},"Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks",[46],[61],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},"Xenon Medical Affairs","CONTACT","1-604-484-3300","XenonCares@xenon-pharma.com",[67,81,91,100,110,119,128,137,146,155,161,170,179,189,199,208,217,226,235,244,254,263,271,277,286,296,302,311,320,329,339,349,359,368,378,384,394,404,413,423,433,443,452,462,468,477],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":25},"IMA Clinical Research Phoenix","RECRUITING","Phoenix","Arizona","85012","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-112.07404,33.44838,{"lat":79,"lon":78},{"facility":82,"status":69,"city":83,"state":84,"zip":85,"country":73,"countryCode":74,"cosmosGeoPoint":86,"geoPoint":90,"contacts":25},"Woodland International Research Group","Little Rock","Arkansas","72211",{"type":76,"coordinates":87},[88,89],-92.28959,34.74648,{"lat":89,"lon":88},{"facility":92,"status":69,"city":93,"state":84,"zip":94,"country":73,"countryCode":74,"cosmosGeoPoint":95,"geoPoint":99,"contacts":25},"Woodland Research Northwest","Rogers","72758",{"type":76,"coordinates":96},[97,98],-94.11854,36.33202,{"lat":98,"lon":97},{"facility":101,"status":69,"city":102,"state":103,"zip":104,"country":73,"countryCode":74,"cosmosGeoPoint":105,"geoPoint":109,"contacts":25},"Behavioral Research Specialists, Llc","Glendale","California","91206",{"type":76,"coordinates":106},[107,108],-118.25508,34.14251,{"lat":108,"lon":107},{"facility":111,"status":69,"city":112,"state":103,"zip":113,"country":73,"countryCode":74,"cosmosGeoPoint":114,"geoPoint":118,"contacts":25},"Marvel Clinical Research","Huntington Beach","92647",{"type":76,"coordinates":115},[116,117],-117.99923,33.6603,{"lat":117,"lon":116},{"facility":120,"status":69,"city":121,"state":103,"zip":122,"country":73,"countryCode":74,"cosmosGeoPoint":123,"geoPoint":127,"contacts":25},"Irvine Clinical Research","Irvine","92614",{"type":76,"coordinates":124},[125,126],-117.82311,33.66946,{"lat":126,"lon":125},{"facility":129,"status":69,"city":130,"state":103,"zip":131,"country":73,"countryCode":74,"cosmosGeoPoint":132,"geoPoint":136,"contacts":25},"CalNeuro Research Group, Inc.","Los Angeles","90025",{"type":76,"coordinates":133},[134,135],-118.24368,34.05223,{"lat":135,"lon":134},{"facility":138,"status":69,"city":139,"state":103,"zip":140,"country":73,"countryCode":74,"cosmosGeoPoint":141,"geoPoint":145,"contacts":25},"Excell Research Inc.","Oceanside","92056",{"type":76,"coordinates":142},[143,144],-117.37948,33.19587,{"lat":144,"lon":143},{"facility":147,"status":69,"city":148,"state":103,"zip":149,"country":73,"countryCode":74,"cosmosGeoPoint":150,"geoPoint":154,"contacts":25},"Atp Clinical Research","Orange","92866",{"type":76,"coordinates":151},[152,153],-117.85311,33.78779,{"lat":153,"lon":152},{"facility":156,"status":69,"city":148,"state":103,"zip":157,"country":73,"countryCode":74,"cosmosGeoPoint":158,"geoPoint":160,"contacts":25},"Nrc Research Institute","92868",{"type":76,"coordinates":159},[152,153],{"lat":153,"lon":152},{"facility":162,"status":69,"city":163,"state":103,"zip":164,"country":73,"countryCode":74,"cosmosGeoPoint":165,"geoPoint":169,"contacts":25},"CenExel CNS-TO (Collaborative Neuroscience Research)","Torrance","90504",{"type":76,"coordinates":166},[167,168],-118.34063,33.83585,{"lat":168,"lon":167},{"facility":171,"status":69,"city":172,"state":103,"zip":173,"country":73,"countryCode":74,"cosmosGeoPoint":174,"geoPoint":178,"contacts":25},"Sunwise Clinical Research","Walnut Creek","94596",{"type":76,"coordinates":175},[176,177],-122.06496,37.90631,{"lat":177,"lon":176},{"facility":180,"status":69,"city":181,"state":182,"zip":183,"country":73,"countryCode":74,"cosmosGeoPoint":184,"geoPoint":188,"contacts":25},"Ct Clinical Research Associates","Cromwell","Connecticut","06416",{"type":76,"coordinates":185},[186,187],-72.64537,41.5951,{"lat":187,"lon":186},{"facility":190,"status":69,"city":191,"state":192,"zip":193,"country":73,"countryCode":74,"cosmosGeoPoint":194,"geoPoint":198,"contacts":25},"CNS Clinical Research Group","Coral Springs","Florida","33067",{"type":76,"coordinates":195},[196,197],-80.2706,26.27119,{"lat":197,"lon":196},{"facility":200,"status":69,"city":201,"state":192,"zip":202,"country":73,"countryCode":74,"cosmosGeoPoint":203,"geoPoint":207,"contacts":25},"NeoClinical Research","Hialeah","33016",{"type":76,"coordinates":204},[205,206],-80.27811,25.8576,{"lat":206,"lon":205},{"facility":209,"status":69,"city":210,"state":192,"zip":211,"country":73,"countryCode":74,"cosmosGeoPoint":212,"geoPoint":216,"contacts":25},"Clinical Neuroscience Solutions, Inc.","Jacksonville","32256",{"type":76,"coordinates":213},[214,215],-81.65565,30.33218,{"lat":215,"lon":214},{"facility":218,"status":69,"city":219,"state":192,"zip":220,"country":73,"countryCode":74,"cosmosGeoPoint":221,"geoPoint":225,"contacts":25},"Accel Research Sites Lakeland","Lakeland","33803",{"type":76,"coordinates":222},[223,224],-81.9498,28.03947,{"lat":224,"lon":223},{"facility":227,"status":69,"city":228,"state":192,"zip":229,"country":73,"countryCode":74,"cosmosGeoPoint":230,"geoPoint":234,"contacts":25},"Accel Research Sites - St. Petersburg-Largo","Largo","33777",{"type":76,"coordinates":231},[232,233],-82.78842,27.90979,{"lat":233,"lon":232},{"facility":236,"status":69,"city":237,"state":192,"zip":238,"country":73,"countryCode":74,"cosmosGeoPoint":239,"geoPoint":243,"contacts":25},"PharmaSouth Research","Miami","33165",{"type":76,"coordinates":240},[241,242],-80.19366,25.77427,{"lat":242,"lon":241},{"facility":245,"status":246,"city":247,"state":192,"zip":248,"country":73,"countryCode":74,"cosmosGeoPoint":249,"geoPoint":253,"contacts":25},"Quantum Clinical Trials","TERMINATED","Miami Beach","33140",{"type":76,"coordinates":250},[251,252],-80.13005,25.79065,{"lat":252,"lon":251},{"facility":255,"status":69,"city":256,"state":192,"zip":257,"country":73,"countryCode":74,"cosmosGeoPoint":258,"geoPoint":262,"contacts":25},"Harmony Clinical Research Inc","North Miami Beach","33162",{"type":76,"coordinates":259},[260,261],-80.16255,25.93315,{"lat":261,"lon":260},{"facility":209,"status":69,"city":264,"state":192,"zip":265,"country":73,"countryCode":74,"cosmosGeoPoint":266,"geoPoint":270,"contacts":25},"Orlando","32801",{"type":76,"coordinates":267},[268,269],-81.37924,28.53834,{"lat":269,"lon":268},{"facility":272,"status":69,"city":264,"state":192,"zip":273,"country":73,"countryCode":74,"cosmosGeoPoint":274,"geoPoint":276,"contacts":25},"Combined Research Orlando Phase I-Iv","32807",{"type":76,"coordinates":275},[268,269],{"lat":269,"lon":268},{"facility":278,"status":69,"city":279,"state":192,"zip":280,"country":73,"countryCode":74,"cosmosGeoPoint":281,"geoPoint":285,"contacts":25},"Panhandle Research and Medical Clinic","Pensacola","32503",{"type":76,"coordinates":282},[283,284],-87.21691,30.42131,{"lat":284,"lon":283},{"facility":287,"status":69,"city":288,"state":289,"zip":290,"country":73,"countryCode":74,"cosmosGeoPoint":291,"geoPoint":295,"contacts":25},"Advanced Discovery Research","Atlanta","Georgia","30318",{"type":76,"coordinates":292},[293,294],-84.38798,33.749,{"lat":294,"lon":293},{"facility":297,"status":69,"city":288,"state":289,"zip":298,"country":73,"countryCode":74,"cosmosGeoPoint":299,"geoPoint":301,"contacts":25},"Synexus - Atlanta","30328",{"type":76,"coordinates":300},[293,294],{"lat":294,"lon":293},{"facility":303,"status":69,"city":304,"state":289,"zip":305,"country":73,"countryCode":74,"cosmosGeoPoint":306,"geoPoint":310,"contacts":25},"CenExel iResearch","Decatur","30030",{"type":76,"coordinates":307},[308,309],-84.29631,33.77483,{"lat":309,"lon":308},{"facility":312,"status":69,"city":313,"state":289,"zip":314,"country":73,"countryCode":74,"cosmosGeoPoint":315,"geoPoint":319,"contacts":25},"Psych Atlanta, Pc","Marietta","30060",{"type":76,"coordinates":316},[317,318],-84.54993,33.9526,{"lat":318,"lon":317},{"facility":321,"status":69,"city":322,"state":289,"zip":323,"country":73,"countryCode":74,"cosmosGeoPoint":324,"geoPoint":328,"contacts":25},"Cenexel Iresearch - Savannah","Savannah","31405",{"type":76,"coordinates":325},[326,327],-81.09983,32.08354,{"lat":327,"lon":326},{"facility":330,"status":69,"city":331,"state":332,"zip":333,"country":73,"countryCode":74,"cosmosGeoPoint":334,"geoPoint":338,"contacts":25},"Northwest Clinical Trials Inc","Boise","Idaho","83704",{"type":76,"coordinates":335},[336,337],-116.20345,43.6135,{"lat":337,"lon":336},{"facility":340,"status":69,"city":341,"state":342,"zip":343,"country":73,"countryCode":74,"cosmosGeoPoint":344,"geoPoint":348,"contacts":25},"Chicago Research Center Inc.","Chicago","Illinois","60634",{"type":76,"coordinates":345},[346,347],-87.65005,41.85003,{"lat":347,"lon":346},{"facility":350,"status":69,"city":351,"state":352,"zip":353,"country":73,"countryCode":74,"cosmosGeoPoint":354,"geoPoint":358,"contacts":25},"Boston Clinical Trials Llc","Boston","Massachusetts","02131",{"type":76,"coordinates":355},[356,357],-71.05977,42.35843,{"lat":357,"lon":356},{"facility":360,"status":69,"city":361,"state":352,"zip":362,"country":73,"countryCode":74,"cosmosGeoPoint":363,"geoPoint":367,"contacts":25},"ELIXIA","Springfield","01103",{"type":76,"coordinates":364},[365,366],-72.58981,42.10148,{"lat":366,"lon":365},{"facility":369,"status":69,"city":370,"state":371,"zip":372,"country":73,"countryCode":74,"cosmosGeoPoint":373,"geoPoint":377,"contacts":25},"IMA Clinical Research Las Vegas","Las Vegas","Nevada","89102",{"type":76,"coordinates":374},[375,376],-115.13722,36.17497,{"lat":376,"lon":375},{"facility":379,"status":69,"city":370,"state":371,"zip":380,"country":73,"countryCode":74,"cosmosGeoPoint":381,"geoPoint":383,"contacts":25},"Redbird Research","89119",{"type":76,"coordinates":382},[375,376],{"lat":376,"lon":375},{"facility":385,"status":69,"city":386,"state":387,"zip":388,"country":73,"countryCode":74,"cosmosGeoPoint":389,"geoPoint":393,"contacts":25},"IMA Clinical Research","Albuquerque","New Mexico","87109",{"type":76,"coordinates":390},[391,392],-106.65114,35.08449,{"lat":392,"lon":391},{"facility":395,"status":69,"city":396,"state":397,"zip":398,"country":73,"countryCode":74,"cosmosGeoPoint":399,"geoPoint":403,"contacts":25},"Integrative Clinical Trials","Brooklyn","New York","11229",{"type":76,"coordinates":400},[401,402],-73.94958,40.6501,{"lat":402,"lon":401},{"facility":405,"status":69,"city":406,"state":397,"zip":407,"country":73,"countryCode":74,"cosmosGeoPoint":408,"geoPoint":412,"contacts":25},"Richmond Behavioral Associates","Staten Island","10314",{"type":76,"coordinates":409},[410,411],-74.13986,40.56233,{"lat":411,"lon":410},{"facility":414,"status":69,"city":415,"state":416,"zip":417,"country":73,"countryCode":74,"cosmosGeoPoint":418,"geoPoint":422,"contacts":25},"New Hope Clinical Research","Charlotte","North Carolina","28211",{"type":76,"coordinates":419},[420,421],-80.84313,35.22709,{"lat":421,"lon":420},{"facility":424,"status":69,"city":425,"state":426,"zip":427,"country":73,"countryCode":74,"cosmosGeoPoint":428,"geoPoint":432,"contacts":25},"Pahl Pharmaceutical Professionals Llc","Oklahoma City","Oklahoma","73112",{"type":76,"coordinates":429},[430,431],-97.51643,35.46756,{"lat":431,"lon":430},{"facility":434,"status":69,"city":435,"state":436,"zip":437,"country":73,"countryCode":74,"cosmosGeoPoint":438,"geoPoint":442,"contacts":25},"Lehigh Center For Clinical Research","Allentown","Pennsylvania","18103",{"type":76,"coordinates":439},[440,441],-75.49018,40.60843,{"lat":441,"lon":440},{"facility":209,"status":69,"city":444,"state":445,"zip":446,"country":73,"countryCode":74,"cosmosGeoPoint":447,"geoPoint":451,"contacts":25},"Memphis","Tennessee","38119",{"type":76,"coordinates":448},[449,450],-90.04898,35.14953,{"lat":450,"lon":449},{"facility":453,"status":69,"city":454,"state":455,"zip":456,"country":73,"countryCode":74,"cosmosGeoPoint":457,"geoPoint":461,"contacts":25},"Delricht Research - Plano","Plano","Texas","75024",{"type":76,"coordinates":458},[459,460],-96.69889,33.01984,{"lat":460,"lon":459},{"facility":463,"status":69,"city":454,"state":455,"zip":464,"country":73,"countryCode":74,"cosmosGeoPoint":465,"geoPoint":467,"contacts":25},"Aim Trials, Llc","75093",{"type":76,"coordinates":466},[459,460],{"lat":460,"lon":459},{"facility":469,"status":69,"city":470,"state":455,"zip":471,"country":73,"countryCode":74,"cosmosGeoPoint":472,"geoPoint":476,"contacts":25},"Grayline Research Center","Wichita Falls","76309",{"type":76,"coordinates":473},[474,475],-98.49339,33.91371,{"lat":475,"lon":474},{"facility":478,"status":69,"city":479,"state":480,"zip":481,"country":73,"countryCode":74,"cosmosGeoPoint":482,"geoPoint":486,"contacts":25},"Core Clinical Research","Everett","Washington","98201",{"type":76,"coordinates":483},[484,485],-122.20208,47.97898,{"lat":485,"lon":484},{"type":488,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100575676",false,"NCT06775379","A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder","X-NOVA2","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age\n* Body Mass Index (BMI) ≤40 kg\u002Fm2\n* Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)\n* Participant's current MDE has a duration of ≥6 weeks and ≤24 months.\n\nKey Exclusion Criteria:\n\n* Participant has a primary diagnosis of a mood disorder other than MDD.\n* Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.\n* Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and\u002For agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.\n* Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \\>1 suicide attempt \\>24 years of age.\n* Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.\n* Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.\n* Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).\n* Participants with medical conditions that may interfere with the purpose or conduct of the study\n* Participant is pregnant, breastfeeding, or planning to become pregnant.","ALL","18 Years","74 Years",{"count":500,"type":501},450,"ESTIMATED","INTERVENTIONAL",[504],"PHASE3","X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)",[507],"Major Depressive Disorder",[509,510,56,40],"Depression","Antidepressant","2025-10-20",{"date":513,"type":514},"2025-10-22","ACTUAL",{"date":516,"type":514},"2024-12-20",{"date":518,"type":501},"2026-10",{"name":5,"class":6},46]