[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569631":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":344,"collaborators":36,"id":346,"slug":347,"hasResults":348,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":36,"eligibilityCriteria":352,"healthyVolunteers":348,"sex":353,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":36,"studyType":359,"phases":360,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":50,"whyStopped":36,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Icalcaprant Dose A","EXPERIMENTAL","Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.",[13],"Drug: Icalcaprant",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: Icalcaprant Dose B","Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Group 3: Placebo for Icalcaprant","PLACEBO_COMPARATOR","Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.",[23],"Drug: Placebo for Icalcaprant",[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Icalcaprant","Oral Capsules",[9,15],[31,32],"ABBV-1354","CVL-354",{"type":26,"name":34,"description":28,"armGroupLabels":35,"otherNames":36},"Placebo for Icalcaprant",[19],null,[38],{"name":39,"affiliation":5,"role":40},"ABBVIE INC.","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[48,62,72,82,92,101,110,119,128,137,147,156,165,171,180,189,198,208,222,231,241,250,260,269,279,289,298,307,316,325,335],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":36},"University of Alabama - Huntsville Regional Medical Campus \u002FID# 272951","RECRUITING","Huntsville","Alabama","35801","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-86.58594,34.7304,{"lat":60,"lon":59},{"facility":63,"status":50,"city":64,"state":65,"zip":66,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":36},"Chandler Clinical Research Trials \u002FID# 274500","Chandler","Arizona","85224",{"type":57,"coordinates":68},[69,70],-111.84125,33.30616,{"lat":70,"lon":69},{"facility":73,"status":50,"city":74,"state":75,"zip":76,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":36},"Sanro Clinical Research Group \u002FID# 279462","Bryant","Arkansas","72022",{"type":57,"coordinates":78},[79,80],-92.48905,34.59593,{"lat":80,"lon":79},{"facility":83,"status":50,"city":84,"state":85,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":36},"Advanced Research Center \u002FID# 272828","Anaheim","California","92805",{"type":57,"coordinates":88},[89,90],-117.9145,33.83529,{"lat":90,"lon":89},{"facility":93,"status":50,"city":94,"state":85,"zip":95,"country":54,"countryCode":55,"cosmosGeoPoint":96,"geoPoint":100,"contacts":36},"Collaborative Neuroscience Research - Garden Grove \u002FID# 271917","Garden Grove","92845",{"type":57,"coordinates":97},[98,99],-117.94145,33.77391,{"lat":99,"lon":98},{"facility":102,"status":50,"city":103,"state":85,"zip":104,"country":54,"countryCode":55,"cosmosGeoPoint":105,"geoPoint":109,"contacts":36},"Catalina Research Institute, LLC \u002FID# 272831","Montclair","91763",{"type":57,"coordinates":106},[107,108],-117.68978,34.07751,{"lat":108,"lon":107},{"facility":111,"status":50,"city":112,"state":85,"zip":113,"country":54,"countryCode":55,"cosmosGeoPoint":114,"geoPoint":118,"contacts":36},"Excell Research \u002FID# 272854","Oceanside","92056",{"type":57,"coordinates":115},[116,117],-117.37948,33.19587,{"lat":117,"lon":116},{"facility":120,"status":50,"city":121,"state":85,"zip":122,"country":54,"countryCode":55,"cosmosGeoPoint":123,"geoPoint":127,"contacts":36},"Pacific Neuropsychiatric Specialists - Orange \u002FID# 273118","Orange","92868",{"type":57,"coordinates":124},[125,126],-117.85311,33.78779,{"lat":126,"lon":125},{"facility":129,"status":50,"city":130,"state":85,"zip":131,"country":54,"countryCode":55,"cosmosGeoPoint":132,"geoPoint":136,"contacts":36},"Schuster Medical Research Institute \u002FID# 272848","Sherman Oaks","91403",{"type":57,"coordinates":133},[134,135],-118.44925,34.15112,{"lat":135,"lon":134},{"facility":138,"status":50,"city":139,"state":140,"zip":141,"country":54,"countryCode":55,"cosmosGeoPoint":142,"geoPoint":146,"contacts":36},"CenExel Hollywood FL \u002FID# 273101","Hollywood","Florida","33024",{"type":57,"coordinates":143},[144,145],-80.14949,26.0112,{"lat":145,"lon":144},{"facility":148,"status":50,"city":149,"state":140,"zip":150,"country":54,"countryCode":55,"cosmosGeoPoint":151,"geoPoint":155,"contacts":36},"Accel Research Sites Network - St. Pete \u002FID# 272962","Largo","33777",{"type":57,"coordinates":152},[153,154],-82.78842,27.90979,{"lat":154,"lon":153},{"facility":157,"status":50,"city":158,"state":140,"zip":159,"country":54,"countryCode":55,"cosmosGeoPoint":160,"geoPoint":164,"contacts":36},"Apg Research \u002FID# 272925","Orlando","32803",{"type":57,"coordinates":161},[162,163],-81.37924,28.53834,{"lat":163,"lon":162},{"facility":166,"status":50,"city":158,"state":140,"zip":167,"country":54,"countryCode":55,"cosmosGeoPoint":168,"geoPoint":170,"contacts":36},"Combined Research Orlando Phase I-IV \u002FID# 279458","32814",{"type":57,"coordinates":169},[162,163],{"lat":163,"lon":162},{"facility":172,"status":50,"city":173,"state":140,"zip":174,"country":54,"countryCode":55,"cosmosGeoPoint":175,"geoPoint":179,"contacts":36},"Clinical Research Center Of Florida \u002FID# 278790","Pompano Beach","33060",{"type":57,"coordinates":176},[177,178],-80.12477,26.23786,{"lat":178,"lon":177},{"facility":181,"status":50,"city":182,"state":140,"zip":183,"country":54,"countryCode":55,"cosmosGeoPoint":184,"geoPoint":188,"contacts":36},"St. Johns Center for Clinical Research - Saint Augustine Location \u002FID# 279465","Saint Augustine","32086",{"type":57,"coordinates":185},[186,187],-81.31452,29.89469,{"lat":187,"lon":186},{"facility":190,"status":50,"city":191,"state":140,"zip":192,"country":54,"countryCode":55,"cosmosGeoPoint":193,"geoPoint":197,"contacts":36},"Neuroscience Institute - West Palm Beach \u002FID# 272922","West Palm Beach","33407",{"type":57,"coordinates":194},[195,196],-80.05337,26.71534,{"lat":196,"lon":195},{"facility":199,"status":50,"city":200,"state":201,"zip":202,"country":54,"countryCode":55,"cosmosGeoPoint":203,"geoPoint":207,"contacts":36},"Georgia Psychiatric Consultants & Advanced Discovery Research \u002FID# 279438","Atlanta","Georgia","30318",{"type":57,"coordinates":204},[205,206],-84.38798,33.749,{"lat":206,"lon":205},{"facility":209,"status":50,"city":210,"state":211,"zip":212,"country":54,"countryCode":55,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Pillar Clinical Research - Chicago \u002FID# 272823","Chicago","Illinois","60641",{"type":57,"coordinates":214},[215,216],-87.65005,41.85003,{"lat":216,"lon":215},[219],{"name":220,"role":44,"phone":221,"phoneExt":36,"email":36},"Site Coordinator","2245347332",{"facility":223,"status":50,"city":224,"state":211,"zip":225,"country":54,"countryCode":55,"cosmosGeoPoint":226,"geoPoint":230,"contacts":36},"Amr Conventions Research \u002FID# 272867","Warrenville","60555",{"type":57,"coordinates":227},[228,229],-88.1734,41.81781,{"lat":229,"lon":228},{"facility":232,"status":50,"city":233,"state":234,"zip":235,"country":54,"countryCode":55,"cosmosGeoPoint":236,"geoPoint":240,"contacts":36},"St. Charles Psychiatric Associates \u002FID# 279239","Saint Charles","Missouri","63304",{"type":57,"coordinates":237},[238,239],-90.48123,38.78394,{"lat":239,"lon":238},{"facility":242,"status":50,"city":243,"state":243,"zip":244,"country":54,"countryCode":55,"cosmosGeoPoint":245,"geoPoint":249,"contacts":36},"Manhattan Behavioral Medicine \u002FID# 279769","New York","10036",{"type":57,"coordinates":246},[247,248],-74.00597,40.71427,{"lat":248,"lon":247},{"facility":251,"status":50,"city":252,"state":253,"zip":254,"country":54,"countryCode":55,"cosmosGeoPoint":255,"geoPoint":259,"contacts":36},"University Of Cincinnati Medical Center \u002FID# 274160","Cincinnati","Ohio","45219",{"type":57,"coordinates":256},[257,258],-84.51439,39.12711,{"lat":258,"lon":257},{"facility":261,"status":50,"city":262,"state":253,"zip":263,"country":54,"countryCode":55,"cosmosGeoPoint":264,"geoPoint":268,"contacts":36},"The Ohio State University \u002FID# 272954","Columbus","43210",{"type":57,"coordinates":265},[266,267],-82.99879,39.96118,{"lat":267,"lon":266},{"facility":270,"status":50,"city":271,"state":272,"zip":273,"country":54,"countryCode":55,"cosmosGeoPoint":274,"geoPoint":278,"contacts":36},"Sooner Clinical Research \u002FID# 272856","Oklahoma City","Oklahoma","73116",{"type":57,"coordinates":275},[276,277],-97.51643,35.46756,{"lat":277,"lon":276},{"facility":280,"status":50,"city":281,"state":282,"zip":283,"country":54,"countryCode":55,"cosmosGeoPoint":284,"geoPoint":288,"contacts":36},"Community Clinical Research - Austin - Cross Park Drive \u002FID# 272940","Austin","Texas","78754",{"type":57,"coordinates":285},[286,287],-97.74306,30.26715,{"lat":287,"lon":286},{"facility":290,"status":50,"city":291,"state":282,"zip":292,"country":54,"countryCode":55,"cosmosGeoPoint":293,"geoPoint":297,"contacts":36},"Elixia - Houston \u002FID# 279200","Houston","77007",{"type":57,"coordinates":294},[295,296],-95.36327,29.76328,{"lat":296,"lon":295},{"facility":299,"status":50,"city":300,"state":282,"zip":301,"country":54,"countryCode":55,"cosmosGeoPoint":302,"geoPoint":306,"contacts":36},"Mind Matters Psychiatry \u002FID# 273536","Missouri City","77459-5204",{"type":57,"coordinates":303},[304,305],-95.53772,29.61857,{"lat":305,"lon":304},{"facility":308,"status":50,"city":309,"state":282,"zip":310,"country":54,"countryCode":55,"cosmosGeoPoint":311,"geoPoint":315,"contacts":36},"Pillar Clinical Research - Richardson \u002FID# 272821","Richardson","75080",{"type":57,"coordinates":312},[313,314],-96.72972,32.94818,{"lat":314,"lon":313},{"facility":317,"status":50,"city":318,"state":282,"zip":319,"country":54,"countryCode":55,"cosmosGeoPoint":320,"geoPoint":324,"contacts":36},"Family Psychiatry Of The Woodlands \u002FID# 275177","The Woodlands","77381",{"type":57,"coordinates":321},[322,323],-95.48938,30.15799,{"lat":323,"lon":322},{"facility":326,"status":50,"city":327,"state":328,"zip":329,"country":54,"countryCode":55,"cosmosGeoPoint":330,"geoPoint":334,"contacts":36},"Northwest Clinical Research Center \u002FID# 272847","Bellevue","Washington","98007",{"type":57,"coordinates":331},[332,333],-122.20068,47.61038,{"lat":333,"lon":332},{"facility":336,"status":50,"city":337,"state":328,"zip":338,"country":54,"countryCode":55,"cosmosGeoPoint":339,"geoPoint":343,"contacts":36},"Core Clinical Research \u002FID# 272955","Everett","98201",{"type":57,"coordinates":340},[341,342],-122.20208,47.97898,{"lat":342,"lon":341},{"type":345,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100569631","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-oral-icalcaprant-in-adult-participants-with-bipolar-i-or-ii-disorder-100569631",false,"NCT06696755","A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder","A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression","Inclusion Criteria:\n\n* Participants with a diagnosis of bipolar I or II according to the (Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0.2, and currently experiencing an (major depressive episode) MDE beginning at least 4 weeks prior to consent and not exceeding 6 months prior to screening.\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg\u002Fm\\^2.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n* CGI-S-BP score of ≥ 4 for depression and overall bipolar illness at screening (Visit 1) and baseline (Visit 2).\n* YMRS total score ≤ 12 at screening (Visit 1) and baseline (Visit 2).\n* Participants on treatment with a single mood stabilizer (lithium, valproate, or lamotrigine), maintained at a stable dose for ≥ 28 days prior to screening. Current mood stabilizer dose must remain unchanged for the duration of the study.\n\n  * If taking lithium or valproate, participant must have a therapeutic blood level at screening of lithium (0.8 - 1.2 mg\u002FdL) or valproate (50 - 125 mg\u002FdL).\n  * If taking lamotrigine, participant must be taking a locally approved maintenance dose.\n\nExclusion Criteria:\n\n* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and\u002For other products in the same class.\n* History of or active medical conditions(s) that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included in the study).","ALL","18 Years","65 Years",{"count":357,"type":358},195,"ESTIMATED","INTERVENTIONAL",[361],"PHASE2","Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder.\n\nIcalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States of America.\n\nParticipants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period.\n\nThere may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[364,365],"Bipolar I Disorder","Bipolar II Disorder",[364,365,367,368,31,32],"Bipolar Disorder","lcalcaprant","2026-05-11",{"date":371,"type":372},"2026-05-13","ACTUAL",{"date":374,"type":372},"2026-02-03",{"date":376,"type":358},"2027-11",{"name":5,"class":6},31]