[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Axsome Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":194},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,84,110,135,165],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100630172",false,"NCT07484217","Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol","A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms","CLARITY","Inclusion Criteria:\n\n* Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT\n* Excessive daytime sleepiness symptoms\n* Able to comply with study procedures\n* Male or female, aged 18 to 65 years inclusive\n\nExclusion Criteria:\n\n* Any clinically significant medical (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms\n* Unable to comply with study procedures\n* Medically inappropriate for study participation in the opinion of the investigator","ALL","18 Years","65 Years",{"count":20,"type":21},508,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.",[27],"Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms",[29,30,31,32,33,34,35,36,37,38,39],"Solriamfetol","Sunosi","Major Depressive Disorder with excessive daytime sleepiness","Major Depressive Disorder","MDD","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","Trace amine-associated receptor 1 (TAAR1) agonist","Excessive daytime sleepiness","EDS","RECRUITING","2026-03-16",{"date":43,"type":44},"2026-03-20","ACTUAL",{"date":46,"type":44},"2026-02-23",{"date":48,"type":21},"2028-12",{"name":50,"class":51},"Axsome Therapeutics, Inc.","INDUSTRY",13,{"id":54,"slug":4,"hasResults":10,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100623575","NCT07398417","Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design","A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia","FORWARD","Inclusion Criteria:\n\n* Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.\n* Male or female, ≥18 years of age.\n* Provides written informed consent to participate in the study before conducting any study procedures.\n\nExclusion Criteria:\n\n* Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.",{"count":61,"type":21},620,[24],"The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.",[65],"Fibromyalgia",[65,67,68,69,70,71,72,73,34,74],"Central Sensitization","Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of the norepinephrine transporter (NET)","Esreboxetine","AXS-14","Norepinephrine reuptake inhibitor","2026-02-04",{"date":77,"type":44},"2026-02-09",{"date":79,"type":44},"2026-01-14",{"date":81,"type":21},"2028-03",{"name":50,"class":51},16,{"id":85,"slug":4,"hasResults":10,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100559763","NCT06568367","Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)","A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder","Inclusion Criteria:\n\n* Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)\n* Provides written informed consent to participate in the study before the conduct of any study procedures.\n* Male or female, aged 18 to 65 inclusive.\n\nExclusion Criteria:\n\n* Prior exposure to solriamfetol\u002FSunosi, through either a clinical study or prescription.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.",{"count":91,"type":21},520,[24],"SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).",[95,96],"Excessive Sleepiness","Shift-work Disorder",[95,29,30,98,36,35,99,100,37],"SWD","Insomnia","Circadian Rhythm Sleep Disorder","2025-11-20",{"date":103,"type":44},"2025-11-25",{"date":105,"type":44},"2024-08-01",{"date":107,"type":21},"2026-12",{"name":50,"class":51},40,{"id":111,"slug":4,"hasResults":10,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100547858","NCT06413433","Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol","A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)","ENGAGE","Inclusion Criteria:\n\n* Primary diagnosis of BED according to DSM-5 criteria.\n* Provides written informed consent to participate in the study before the conduct of any study procedures.\n* Male or female, aged 18 to 55 inclusive.\n\nExclusion Criteria:\n\n* Prior exposure to solriamfetol\u002FSunosi, through either a clinical study or prescription.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","55 Years",{"count":119,"type":21},450,[24],"ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.",[123],"Binge-Eating Disorder",[125,126,29,30,34,35,36,37],"Binge eating disorder","BED",{"date":128,"type":44},"2025-11-21",{"date":130,"type":44},"2024-04-26",{"date":132,"type":21},"2025-12",{"name":50,"class":51},45,{"id":136,"slug":4,"hasResults":10,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":109},"100533289","NCT06223880","A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms","A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms","Inclusion Criteria:\n\n* Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features\n* Current major depressive episode of at least 4 weeks in duration\n\nExclusion Criteria:\n\n* Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.\n* Unable to comply with study procedures\n* Medically inappropriate for study participation in the opinion of the investigator",{"count":142,"type":21},350,[144],"PHASE4","This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.",[32],[148,149,150,33,151,152,153,154,74,155,156],"AXS-05","Dextromethorphan","Bupropion","Depression","Relapse of depressive symptoms","NMDA receptor antagonist","Sigma-1 receptor agonist","Dopamine reuptake inhibitor","Axsome Therapeutics","2025-01-21",{"date":159,"type":44},"2025-01-23",{"date":161,"type":44},"2023-12-27",{"date":163,"type":21},"2026-03",{"name":50,"class":51},{"id":166,"slug":4,"hasResults":10,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":10,"sex":171,"minAge":4,"maxAge":4,"enrollmentInfo":172,"targetDuration":174,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100547857","NCT06413420","SUNOSI® (Solriamfetol) Pregnancy Registry","SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant women of any age\n* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy\n* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA\n* Provides written informed consent to participate in the study\n* Authorization for her HCP(s) to provide data to the registry\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)\n* Inclusion of a prior pregnancy in the main analysis population","FEMALE",{"count":173,"type":21},1731,"12 Months","OBSERVATIONAL","The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).",[178,179,180],"Narcolepsy","Obstructive Sleep Apnea","Pregnant Women and Their Offspring",[29,182,34,178,179,35,36,183,184],"SUNOSI","Pregnancy outcomes","Infant outcomes","2024-05-09",{"date":187,"type":44},"2024-05-14",{"date":189,"type":44},"2019-07-31",{"date":191,"type":21},"2029-09",{"name":50,"class":51},2,""]