[{"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:":200},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,86,113,139,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100630172","phase-3-clinical-assessment-of-response-in-the-treatment-of-depression-with-daytime-sleepiness-using-solriamfetol-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":21,"type":22},508,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms",[30,31,32,33,34,35,36,37,38,39,40],"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":44,"type":45},"2026-03-20","ACTUAL",{"date":47,"type":45},"2026-02-23",{"date":49,"type":22},"2028-12",{"name":51,"class":52},"Axsome Therapeutics, Inc.","INDUSTRY",13,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100623575","phase-3-fibromyalgia-response-with-esreboxetine-evaluated-using-a-randomized-withdrawal-research-design-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":63,"type":22},620,[25],"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.",[67],"Fibromyalgia",[67,69,70,71,72,73,74,75,35,76],"Central Sensitization","Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of the norepinephrine transporter (NET)","Esreboxetine","AXS-14","Norepinephrine reuptake inhibitor","2026-02-04",{"date":79,"type":45},"2026-02-09",{"date":81,"type":45},"2026-01-14",{"date":83,"type":22},"2028-03",{"name":51,"class":52},16,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100559763","phase-3-studying-solriamfetol-modulation-of-taar-1-dopamine-and-norepinephrine-in-shift-work-disorder-sustain-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":94,"type":22},520,[25],"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).",[98,99],"Excessive Sleepiness","Shift-work Disorder",[98,30,31,101,37,36,102,103,38],"SWD","Insomnia","Circadian Rhythm Sleep Disorder","2025-11-20",{"date":106,"type":45},"2025-11-25",{"date":108,"type":45},"2024-08-01",{"date":110,"type":22},"2026-12",{"name":51,"class":52},40,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100547858","phase-3-elucidating-taar-1-dopamine-and-norepinephrine-in-binge-eating-disorder-using-solriamfetol-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":123,"type":22},450,[25],"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.",[127],"Binge-Eating Disorder",[129,130,30,31,35,36,37,38],"Binge eating disorder","BED",{"date":132,"type":45},"2025-11-21",{"date":134,"type":45},"2024-04-26",{"date":136,"type":22},"2025-12",{"name":51,"class":52},45,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":112},"100533289","phase-4-a-study-to-evaluate-the-efficacy-of-axs-05-compared-to-bupropion-in-preventing-the-relapse-of-depressive-symptoms-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":147,"type":22},350,[149],"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.",[33],[153,154,155,34,156,157,158,159,76,160,161],"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":164,"type":45},"2025-01-23",{"date":166,"type":45},"2023-12-27",{"date":168,"type":22},"2026-03",{"name":51,"class":52},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":177,"minAge":4,"maxAge":4,"enrollmentInfo":178,"targetDuration":180,"studyType":181,"phases":4,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100547857","sunosi-solriamfetol-pregnancy-registry-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":179,"type":22},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).",[184,185,186],"Narcolepsy","Obstructive Sleep Apnea","Pregnant Women and Their Offspring",[30,188,35,184,185,36,37,189,190],"SUNOSI","Pregnancy outcomes","Infant outcomes","2024-05-09",{"date":193,"type":45},"2024-05-14",{"date":195,"type":45},"2019-07-31",{"date":197,"type":22},"2029-09",{"name":51,"class":52},2,""]