[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LivaNova\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100353886","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-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":19,"type":20},6800,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Treatment Resistant Depression",[28,29,30],"VNS","Depression","TRD","RECRUITING","2026-06-11",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":35},"2019-09-26",{"date":39,"type":20},"2030-12-31",{"name":41,"class":42},"LivaNova","INDUSTRY",101,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100310356","a-study-to-assess-effectiveness-and-efficiency-of-vns-therapy-in-patients-with-difficult-to-treat-depression-100310356","NCT03320304","A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.","A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.","RESTORE-LIFE","Inclusion Criteria:\n\n* Be at least 18 years of age.\n* Have a documented primary diagnosis of chronic (\\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.\n* Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).\n* Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).\n* Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance\u002Falcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)\n\nExclusion Criteria:\n\nThere are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.",{"count":53,"type":20},500,"5 Years","OBSERVATIONAL","The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.",[26],[59,30,60,61,28],"Difficult to Treat Depression","VNS Therapy","Vagus Nerve Stimulation","2026-01-22",{"date":64,"type":35},"2026-01-26",{"date":66,"type":35},"2017-12-14",{"date":68,"type":20},"2031-12-01",{"name":41,"class":42},18,""]