[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630172":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":22,"studyPopulation":11,"armGroups":23,"interventions":36,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":169,"collaborators":11,"id":171,"slug":11,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":11,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"Axsome Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time from randomization to relapse of depressive symptoms",null,"Up to 24 weeks.",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":19},"DOUBLE",[20,21],"PARTICIPANT","INVESTIGATOR","The study will consist of a screening period, an open label solriamfetol treatment period, a double-blind randomized withdrawal period, and a follow-up period. Eligible subjects will be treated with open-label solriamfetol and monitored for clinical response. Subjects achieving clinical response will be randomized into the double-blind randomized withdrawal period in a 1:1 ratio to either continued treatment with solriamfetol or to switch to placebo, for the remainder of the double-blind period or until they experience relapse of depressive symptoms.",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Solriamfetol 150mg","EXPERIMENTAL","* In the open-label period;\n* In the randomized double-blind period (if applicable)",[29],"Drug: Solriamfetol 150 MG",{"label":31,"type":32,"description":33,"interventionNames":34},"Placebo","PLACEBO_COMPARATOR","• In the randomized double-blind period (if applicable)",[35],"Drug: Placebo",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DRUG","Solriamfetol 150 MG","Solriamfetol tablets, taken once daily",[25],{"type":38,"name":31,"description":43,"armGroupLabels":44,"otherNames":11},"Placebo tablets, taken once daily",[31],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Study Director","CONTACT","2123325061","sol-mdd-302@axsome.com",[52,66,74,82,91,99,108,116,125,133,142,151,160],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":11},"Clinical Research Site","RECRUITING","Chino","California","91710","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.68894,34.01223,{"lat":64,"lon":63},{"facility":53,"status":54,"city":67,"state":56,"zip":68,"country":58,"countryCode":59,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Redlands","92374",{"type":61,"coordinates":70},[71,72],-117.18254,34.05557,{"lat":72,"lon":71},{"facility":53,"status":54,"city":75,"state":56,"zip":76,"country":58,"countryCode":59,"cosmosGeoPoint":77,"geoPoint":81,"contacts":11},"Walnut Creek","94596",{"type":61,"coordinates":78},[79,80],-122.06496,37.90631,{"lat":80,"lon":79},{"facility":53,"status":54,"city":83,"state":84,"zip":85,"country":58,"countryCode":59,"cosmosGeoPoint":86,"geoPoint":90,"contacts":11},"Jacksonville","Florida","32256",{"type":61,"coordinates":87},[88,89],-81.65565,30.33218,{"lat":89,"lon":88},{"facility":53,"status":54,"city":92,"state":84,"zip":93,"country":58,"countryCode":59,"cosmosGeoPoint":94,"geoPoint":98,"contacts":11},"Miami","33176",{"type":61,"coordinates":95},[96,97],-80.19366,25.77427,{"lat":97,"lon":96},{"facility":53,"status":54,"city":100,"state":101,"zip":102,"country":58,"countryCode":59,"cosmosGeoPoint":103,"geoPoint":107,"contacts":11},"Cherry Hill","New Jersey","08002",{"type":61,"coordinates":104},[105,106],-75.03073,39.93484,{"lat":106,"lon":105},{"facility":53,"status":54,"city":109,"state":101,"zip":110,"country":58,"countryCode":59,"cosmosGeoPoint":111,"geoPoint":115,"contacts":11},"Toms River","08755",{"type":61,"coordinates":112},[113,114],-74.19792,39.95373,{"lat":114,"lon":113},{"facility":53,"status":54,"city":117,"state":118,"zip":119,"country":58,"countryCode":59,"cosmosGeoPoint":120,"geoPoint":124,"contacts":11},"Brooklyn","New York","11235",{"type":61,"coordinates":121},[122,123],-73.94958,40.6501,{"lat":123,"lon":122},{"facility":53,"status":54,"city":126,"state":118,"zip":127,"country":58,"countryCode":59,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"The Bronx","10464",{"type":61,"coordinates":129},[130,131],-73.86641,40.84985,{"lat":131,"lon":130},{"facility":53,"status":54,"city":134,"state":135,"zip":136,"country":58,"countryCode":59,"cosmosGeoPoint":137,"geoPoint":141,"contacts":11},"Cincinnati","Ohio","45215",{"type":61,"coordinates":138},[139,140],-84.51439,39.12711,{"lat":140,"lon":139},{"facility":53,"status":54,"city":143,"state":144,"zip":145,"country":58,"countryCode":59,"cosmosGeoPoint":146,"geoPoint":150,"contacts":11},"Portland","Oregon","97210",{"type":61,"coordinates":147},[148,149],-122.67621,45.52345,{"lat":149,"lon":148},{"facility":53,"status":54,"city":152,"state":153,"zip":154,"country":58,"countryCode":59,"cosmosGeoPoint":155,"geoPoint":159,"contacts":11},"Memphis","Tennessee","38119",{"type":61,"coordinates":156},[157,158],-90.04898,35.14953,{"lat":158,"lon":157},{"facility":53,"status":54,"city":161,"state":162,"zip":163,"country":58,"countryCode":59,"cosmosGeoPoint":164,"geoPoint":168,"contacts":11},"Dallas","Texas","75243",{"type":61,"coordinates":165},[166,167],-96.80667,32.78306,{"lat":167,"lon":166},{"type":170,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":182,"type":183},508,"ESTIMATED","INTERVENTIONAL",[186],"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.",[189],"Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms",[191,192,193,194,195,196,197,198,199,200,201],"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","2026-03-16",{"date":204,"type":205},"2026-03-20","ACTUAL",{"date":207,"type":205},"2026-02-23",{"date":209,"type":183},"2028-12",{"name":5,"class":6},13]