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Edwards School of Medicine","Huntington","West Virginia","25701",{"type":48,"coordinates":1282},[1283,1284],-82.44515,38.41925,{"lat":1284,"lon":1283},[1287,1291],{"name":1288,"role":35,"phone":1289,"phoneExt":37,"email":1290},"Dakota May, MD","304-691-1500","May110@marshall.edu",{"name":1288,"role":31,"phone":37,"phoneExt":37,"email":37},{"facility":1293,"status":89,"city":1294,"state":1279,"zip":1295,"country":46,"cosmosGeoPoint":1296,"geoPoint":1300,"contacts":37},"West Virginia Clinical and Translational Science Institute","Morgantown","26506",{"type":48,"coordinates":1297},[1298,1299],-79.9559,39.62953,{"lat":1299,"lon":1298},{"facility":1302,"status":42,"city":1303,"state":1304,"zip":1305,"country":46,"cosmosGeoPoint":1306,"geoPoint":1310,"contacts":1311},"University of Wisconsin","Madison","Wisconsin","53719",{"type":48,"coordinates":1307},[1308,1309],-89.40123,43.07305,{"lat":1309,"lon":1308},[1312,1316],{"name":1313,"role":35,"phone":1314,"phoneExt":37,"email":1315},"Rick Stauffacher","608-262-7722","rstauffach@clinicaltrials.wisc.edu",{"name":1317,"role":31,"phone":37,"phoneExt":37,"email":37},"Steven Garlow",{"type":1319,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100353886",false,"NCT03887715","A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression","RECOVER","Inclusion Criteria:\n\nThe patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.\n\nThe patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.\n\nThe patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.\n\nPatients must maintain a stable medication regimen for at least four weeks before device implantation.\n\nExclusion Criteria:\n\nCurrent or lifetime history of psychotic features in any MDE;\n\nCurrent or lifetime history of schizophrenia or schizoaffective disorder;\n\nCurrent or lifetime history of any other psychotic disorder;\n\nCurrent or lifetime history of rapid cycling bipolar disorder;\n\nCurrent secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;\n\nCurrent suicidal intent; or\n\nTreatment with another investigational device or investigational drugs.","ALL","18 Years",{"count":1329,"type":1330},6800,"ESTIMATED","INTERVENTIONAL",[1333],"NA","Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.",[1336],"Treatment Resistant Depression",[26,1338,1339],"Depression","TRD","2026-06-11",{"date":1342,"type":1343},"2026-06-15","ACTUAL",{"date":1345,"type":1343},"2019-09-26",{"date":1347,"type":1330},"2030-12-31",{"name":5,"class":6},101]