[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610506":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":113,"collaborators":115,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":12,"enrollmentInfo":137,"targetDuration":12,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":54,"whyStopped":12,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"King's College London","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as usual (TAU)","NO_INTERVENTION","Treatment as usual will consist of standard care, such as psychotherapy and\u002For antidepressant medication or no treatment, as decided by participant and treating clinician.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"transcranial direct current stimulation + treatment as usual (tDCS + TAU)","EXPERIMENTAL","In addition to receiving treatment as usual, participants randomized to receive tDCS will engage in a 10-week treatment protocol of active tDCS which participants will administer at home. Stimulation schedule is 5 sessions per week for 3 weeks followed by 3 sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS device is headset with bifrontal montage, anode at left dorsolateral prefrontal cortex (DLPFC) and cathode at right DLPFC (EEG positions F3 and F4, respectively). Stimulation is 2 mA for 30 minutes with a gradual ramp up over 30 seconds. Electrode area is 23 cm2.",[18],"Device: transcranial direct current stimulation (tDCS)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","transcranial direct current stimulation (tDCS)","Participants randomised to the tDCS treatment arm will use a tDCS device which is a headset with the anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4, respectively). Treatment protocol consists of 5 tDCS sessions per week for 3 weeks followed by 3 tDCS sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS stimulation is 2 mA for 30 minutes with gradual ramp up over 30 seconds at the start and end of each session.",[14],[26],{"name":27,"affiliation":5,"role":28},"Cynthia Fu, MD, PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Cynthia Fu","CONTACT","020 7848 0002","cynthia.fu@kcl.ac.uk",[36,52,65,77,89,101],{"facility":37,"status":38,"city":39,"state":12,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cardiff and Vale Health Board","NOT_YET_RECRUITING","Cardiff","CF24 4HQ","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-3.18,51.48,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":12,"phoneExt":12,"email":12},"Neil Harrison",{"facility":53,"status":54,"city":55,"state":12,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"South London and Maudsley NHS Foundation Trust","RECRUITING","London","SE5 8AF",{"type":44,"coordinates":58},[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":12,"phoneExt":12,"email":12},"Cynthia Fu, MD, MSc, PhD",{"facility":66,"status":38,"city":67,"state":12,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust","Newcastle","NE4 5PL",{"type":44,"coordinates":70},[71,72],-5.88979,54.21804,{"lat":72,"lon":71},[75],{"name":76,"role":28,"phone":12,"phoneExt":12,"email":12},"Stuart Watson",{"facility":78,"status":38,"city":79,"state":12,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Northamptonshire Healthcare NHS Foundation Trust","Northampton","NN5 6UD",{"type":44,"coordinates":82},[83,84],-0.88333,52.25,{"lat":84,"lon":83},[87],{"name":88,"role":28,"phone":12,"phoneExt":12,"email":12},"Chris Griffiths",{"facility":90,"status":38,"city":91,"state":12,"zip":92,"country":41,"countryCode":42,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Nottinghamshire Healthcare NHS Foundation Trust","Nottingham","NG7 2UH",{"type":44,"coordinates":94},[95,96],-1.15047,52.9536,{"lat":96,"lon":95},[99],{"name":100,"role":28,"phone":12,"phoneExt":12,"email":12},"Sudheer Lankappa",{"facility":102,"status":38,"city":103,"state":12,"zip":104,"country":41,"countryCode":42,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Hampshire and Isle of Wight Healthcare NHS Foundation Trust","Southampton","SO14 3DT",{"type":44,"coordinates":106},[107,108],-1.40428,50.90395,{"lat":108,"lon":107},[111],{"name":112,"role":28,"phone":12,"phoneExt":12,"email":12},"David Baldwin",{"type":114,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[116,119,121,123,124,125],{"name":117,"class":118},"Nottinghamshire Healthcare NHS Trust","OTHER_GOV",{"name":120,"class":118},"Cardiff and Vale University Health Board",{"name":122,"class":6},"Northumberland, Tyne and Wear NHS Foundation Trust",{"name":78,"class":6},{"name":53,"class":6},{"name":126,"class":6},"Southern Health NHS Foundation Trust","100610506","home-based-transcranial-direct-current-stimulation-in-major-depressive-disorder-home-100610506",false,"NCT07228468","Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)","Home-Based Transcranial Direct Current Stimulation in Major Depressive Disorder: a Multi-Centre, Two-Parallel Group, Superiority Randomised Controlled Trial","HOME","Inclusion Criteria:\n\n1. Adults aged 18 years or over\n2. Current episode of depression based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (APA, 2013) for major depressive disorder (MDD) as assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998)\n3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS\n4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.\n5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.\n6. Being under the care of GP\n7. Agreeable for GP to be regularly informed about study participation\n8. Able to provide written, informed consent\n\nExclusion Criteria:\n\n1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011)\n2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI\n3. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)\n4. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of 8 or more in Alcohol use disorders identification test consumption (AUDIT C) (Khadjesari et al., 2017; NICE, 2023)\n5. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation\n6. History of esketamine \u002F ketamine for treatment of depression\n7. History of psychosurgery for depression\n8. Having cognitive impairment (e.g. dementia)\n9. Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease)\n10. Have any implant in the brain or neurocranial defect\n11. Have shrapnel or any ferromagnetic material in the head\n12. Have any active implantable medical device (e.g. pacemaker)\n13. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study\n14. Concurrent enrolment in another interventional study","ALL","18 Years",{"count":138,"type":139},438,"ESTIMATED","INTERVENTIONAL",[142],"NA","Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell.\n\nThe novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether home-based tDCS is an effective treatment for major depression for adults with major depression.\n\nParticipants will be randomised to receive either a 10-week course of active tDCS treatment in addition to their standard care (Treatment as Usual), or to only receive Treatment as Usual. Participants will be followed up for 6-months after the start of the treatment began.\n\nAfter the 6-month follow-up visit, all participants from both groups can choose to continue\u002Fstart the tDCS treatment. There will be a final follow-up visit 3 months later (9 months from the original treatment start of the trial).",[145],"Major Depressive Disorder (MDD)",[147,148,149,150,151,152],"transcranial direct current stimulation","tDCS","major depression","MDD","major depressive disorder","brain stimulation","2026-01-23",{"date":155,"type":156},"2026-01-26","ACTUAL",{"date":158,"type":156},"2025-11-18",{"date":160,"type":139},"2027-12-31",{"name":5,"class":6},6]