[{"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:":270},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,55,88,117,146,170,195,214,240],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100651844","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-axs-05-for-smoking-cessation-in-adults-100651844",false,"NCT07766655","A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults","A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults","Inclusion Criteria:\n\n* Male or female, aged 18 to 65 (inclusive)\n\nExclusion Criteria:\n\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},705,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.",[27],"Smoking Cessation",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Smoking cessation","Smoking","Cigarettes","AXS-05","Auvelity","Axsome Therapeutics","Dopamine reuptake inhibitor","Norepinephrine reuptake inhibitor","Dextromethorphan","Bupropion","NMDA Receptor Antagonist","Glutamate Modulator","Sigma-1 Receptor Agonist","Nicotinic Acetylcholine Receptor Antagonist","RECRUITING","2026-08-11",{"date":46,"type":47},"2026-08-14","ACTUAL",{"date":49,"type":21},"2026-08",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Axsome Therapeutics, Inc.","INDUSTRY",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"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":65,"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.",[69],"Binge-Eating Disorder",[71,72,73,74,75,76,77,78],"Binge eating disorder","BED","Solriamfetol","Sunosi","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","Trace amine-associated receptor 1 (TAAR1) agonist","2026-07-27",{"date":81,"type":47},"2026-07-28",{"date":83,"type":47},"2024-04-26",{"date":85,"type":21},"2026-12",{"name":53,"class":54},45,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100630172","phase-3-clinical-assessment-of-response-in-the-treatment-of-depression-with-daytime-sleepiness-using-solriamfetol-100630172","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",{"count":97,"type":21},508,[24],"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.",[101],"Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms",[73,74,103,104,105,75,76,77,78,106,107],"Major Depressive Disorder with excessive daytime sleepiness","Major Depressive Disorder","MDD","Excessive daytime sleepiness","EDS","2026-07-23",{"date":110,"type":47},"2026-07-24",{"date":112,"type":47},"2026-02-23",{"date":114,"type":21},"2028-12",{"name":53,"class":54},40,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"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":126,"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.",[130],"Fibromyalgia",[130,132,133,134,135,136,137,138,75,36],"Central Sensitization","Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of the norepinephrine transporter (NET)","Esreboxetine","AXS-14",{"date":110,"type":47},{"date":141,"type":47},"2026-01-14",{"date":143,"type":21},"2028-03",{"name":53,"class":54},51,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":169},"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":154,"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).",[158,159],"Excessive Sleepiness","Shift-work Disorder",[158,73,74,161,77,76,162,163,78],"SWD","Insomnia","Circadian Rhythm Sleep Disorder",{"date":110,"type":47},{"date":166,"type":47},"2024-08-01",{"date":85,"type":21},{"name":53,"class":54},49,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":5},"100648128","phase-3-a-study-to-assess-the-efficacy-and-safety-of-solriamfetol-in-adolescents-with-adhd-100648128","NCT07717892","A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD","A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to \u003C18 Years With Attention Deficit Hyperactivity Disorder (ADHD)","Inclusion Criteria:\n\n* Male or female, aged 12 to \\\u003C18 years.\n* Primary diagnosis of ADHD according to DSM-5 criteria.\n* Has parents\u002Flegal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.\n\nExclusion Criteria:\n\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","12 Years","17 Years",{"count":180,"type":21},468,[24],"This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to \\\u003C18 years with ADHD.",[184],"ADHD",[186,184,74,73,75,76,77],"Attention deficit hyperactivity disorder","2026-07-16",{"date":189,"type":47},"2026-07-21",{"date":191,"type":47},"2026-06-25",{"date":193,"type":21},"2028-06-30",{"name":53,"class":54},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":5},"100648122","phase-3-a-study-to-assess-the-efficacy-and-safety-of-solriamfetol-in-children-with-adhd-100648122","NCT07717879","A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD","A Phase 3, Randomized, 6-Week, Double-blind, Placebo-controlled Trial of Solriamfetol in Children Aged 6 to \u003C12 Years With Attention Deficit Hyperactivity Disorder (ADHD)","Inclusion Criteria:\n\n* Male or female, aged 6 to \\\u003C12 years.\n* Primary diagnosis of ADHD according to DSM-5 criteria.\n* Has parents\u002Flegal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.\n\nExclusion Criteria:\n\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","6 Years","11 Years",{"count":180,"type":21},[24],"This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to \\\u003C12 years with ADHD.",[184],[186,184,74,73,75,76,77],{"date":189,"type":47},{"date":211,"type":47},"2026-07-06",{"date":193,"type":21},{"name":53,"class":54},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":116},"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":222,"type":21},350,[224],"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.",[104],[32,37,38,105,228,229,230,231,36,35,34],"Depression","Relapse of depressive symptoms","NMDA receptor antagonist","Sigma-1 receptor agonist","2025-01-21",{"date":234,"type":47},"2025-01-23",{"date":236,"type":47},"2023-12-27",{"date":238,"type":21},"2026-03",{"name":53,"class":54},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":247,"minAge":4,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":251,"phases":4,"briefSummary":252,"conditions":253,"keywords":257,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"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":249,"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).",[254,255,256],"Narcolepsy","Obstructive Sleep Apnea","Pregnant Women and Their Offspring",[73,258,75,254,255,76,77,259,260],"SUNOSI","Pregnancy outcomes","Infant outcomes","2024-05-09",{"date":263,"type":47},"2024-05-14",{"date":265,"type":47},"2019-07-31",{"date":267,"type":21},"2029-09",{"name":53,"class":54},2,""]