[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446757":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":45,"locations":52,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":26,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":26,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"active tDCS","EXPERIMENTAL","2mA of direct current delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.",[13,14],"Device: active tDCS","Other: workbook",{"label":16,"type":17,"description":18,"interventionNames":19},"control","SHAM_COMPARATOR","Sham stimulation where the current is turned off after 30 seconds in a slow ramp down, delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.",[14,20],"Device: sham tDCS",[22,27,31],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"workbook","Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state",[9,16],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"sham tDCS","Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks",[16],[36,40,43],{"name":37,"affiliation":38,"role":39},"Sophie Grigoriadis, MD, PhD","Sunnybrook Health Sciences Centre","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Daniel Blumberger, MD, MSc","Centre for Addiction and Mental Health",{"name":44,"affiliation":5,"role":39},"Simone Vigod, MD, MSc",[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Simoe Vigod","CONTACT","4163236400","4080","simone.vigod@wchospital.ca",[53,72],{"facility":38,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"NOT_YET_RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-79.39864,43.70643,{"lat":64,"lon":63},[67,71],{"name":68,"role":48,"phone":69,"phoneExt":26,"email":70},"Sophie Grigoriadis, MD","416-480-5677","sophie.grigoriadis@sunnybrook.ca",{"name":68,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":5,"status":73,"city":55,"state":56,"zip":74,"country":58,"countryCode":59,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"RECRUITING","M5S1B2",{"type":61,"coordinates":76},[63,64],{"lat":64,"lon":63},[79,81],{"name":80,"role":48,"phone":49,"phoneExt":50,"email":51},"Simone Vigod, MD",{"name":82,"role":39,"phone":26,"phoneExt":26,"email":26},"Simone Vigod",{"type":39,"investigatorFullName":82,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator, Professor of Psychiatry, Senior Scientist",[86,87],{"name":42,"class":6},{"name":38,"class":6},"100446757","rct-of-at-home-tdcs-for-depression-in-pregnancy-100446757",false,"NCT05097586","RCT of At-Home tDCS for Depression in Pregnancy","Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy","Inclusion criteria:\n\n1. Adult, ≥18 years of age\n2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization\n3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)\n4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use\n5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment\n\nExclusion criteria:\n\n1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS\n2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)\n3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview\n4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview\n5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia\u002Feclampsia in current pregnancy or neurologic illness or seizure history\n6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI\u002FCo-I assessment)\n7. Metal implants in cranium or any electrical implants\n8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS\n9. Visibly non-intact skin\u002Frash on scalp areas at stimulation electrode sites\n10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English","FEMALE","18 Years",{"count":98,"type":99},156,"ESTIMATED","INTERVENTIONAL",[102],"NA","This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum",[105,106,107],"Major Depression","Pregnancy","Postpartum Depression",[106,109,110],"Depression","Transcranial direct current stimulation","2025-05-21",{"date":113,"type":114},"2025-05-28","ACTUAL",{"date":116,"type":114},"2021-11-08",{"date":118,"type":99},"2027-06",{"name":5,"class":6},2]