[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596189":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":55,"collaborators":26,"id":57,"slug":26,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Soterix Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tDCS and Mindfulness","EXPERIMENTAL","Application of electrical stimulation to the brain non-invasively combined with mindfulness",[13],"Device: transcranial direct current stimulation (tDCS) and mindfulness instruction",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham tDCS and Mindfulness","SHAM_COMPARATOR","Sham electrical stimulation and mindfulness",[19],"Device: Sham tDCS and Mindfulness",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","transcranial direct current stimulation (tDCS) and mindfulness instruction","tDCS together with audio providing mindfulness instruction and music",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo electrical sitmulation and audio-guided mindfulness instruction",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Paul Thomas Researcher","CONTACT","18889908327","104","trials@soterixmedical.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Soterix Medical, Inc.","RECRUITING","Woodbridge","New Jersey","07095","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.28459,40.5576,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":26,"email":36},"Paul Thomas",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100596189",false,"NCT07042217","Transcranial Direct Current Stimulation for Depression","A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview\n* Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression\n* QIDS-SR score \\>11 on all three days of screening week (Days 1,3, 7)\n* Scored at least 17 (inclusive) on the HDRS-17 at trial entry\n* Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening\n* Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.\n\nExclusion Criteria:\n\n* Failure to respond to at least 2 antidepressant medications\n* Drug or alcohol abuse or dependence in the preceding 3 months\n* Concurrent benzodiazepine medication\n* High suicide risk assessed during clinician screening at baseline interview.\n* Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.\n* Current DSM-V-TR psychotic disorder\n* History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician\n* Metal in the cranium or skull defects\n* Implanted pump, neurostimulator, cardiac pacemaker or defibrillator\n* Skin lesions on scalp at the proposed electrode sites\n* Pregnancy","ALL","22 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.",[73],"Unipolar Depression",[75,76,77,78,79],"tDCS","mindulness","tES","electrotherapy","depression","2025-11-06",{"date":82,"type":83},"2025-11-10","ACTUAL",{"date":85,"type":83},"2025-07-01",{"date":87,"type":67},"2026-09-01",{"name":5,"class":6},1]