[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556732":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":33,"locations":44,"responsibleParty":62,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The Royal Ottawa Mental Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Accelerated iTBS","ACTIVE_COMPARATOR","Intermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks).",[13],"Device: Theta Burst Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard iTBS","Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Theta Burst Stimulation","Cool B70 coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A\u002FS, Farum, Denmark)",[9,15],null,[26,30],{"name":27,"affiliation":28,"role":29},"Sara Tremblay, PhD","The Royal's Institute of Mental Health Research","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Jean-François Lepage, PhD","Sherbrooke University",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Stacey Shim, MSc","CONTACT","613-722-6521","6356","stacey.shim@theroyal.ca",{"name":41,"role":36,"phone":37,"phoneExt":42,"email":43},"Maya El-Outa, BSc","6865","Maya.El-Outa@theroyal.ca",[45],{"facility":28,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Ottawa","Ontario","K1Z 7K4","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-75.69812,45.41117,{"lat":56,"lon":55},[59],{"name":27,"role":36,"phone":37,"phoneExt":60,"email":61},"6227","Sara.Tremblay@theroyal.ca",{"type":29,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Sara Tremblay","Principal Investigator",[66],{"name":67,"class":6},"Université de Sherbrooke","100556732","comparing-the-efficacy-of-accelerated-vs-standard-fmri-guided-itbs-in-treating-adolescents-depression-100556732",false,"NCT06528938","Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression","Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents","Inclusion Criteria:\n\n1. Voluntary and competent to consent.\n2. Ages 16-19 years old.\n3. Can speak and read English.\n4. Primary and\u002For predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).\n5. Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.\n6. Moderate symptoms in the current depressive episode, indexed by a score of at least 40 on the Children's Depression Rating Scale Revised for depression (CDRS-R).\n7. Are able to adhere to the treatment schedule.\n8. Have stable psychotropic medications and\u002For psychotherapy regimen for at least four weeks before participating in the trial.\n\nExclusion Criteria:\n\n1. Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.\n2. Current or past substance (\\\u003C 3 months) (excluding caffeine or nicotine) or alcohol abuse\u002Fdependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past 3 months, moderate to severe would be an exclusion.\n3. Current use of illegal substances or cannabis confirmed by urine screening test.\n4. Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).\n5. Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.\n6. Acute suicidality or life-threatening due to self-neglect.\n7. Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).\n8. Have a specific contraindication to TMS and\u002For MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).\n9. Unwilling to maintain the current antidepressant regimen.\n10. Taking more than 1 mg\u002Fday of lorazepam or equivalent.\n11. Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.","ALL","16 Years","19 Years",{"count":79,"type":80},10,"ESTIMATED","INTERVENTIONAL",[83],"NA","Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once\u002Fdaily rTMS for treatment-resistant depression in adolescents.",[86,87],"Depression","Depressive Disorder, Major",[89,90],"Accelerated rTMS","repetitive Transcranial Magnetic Stimulation","2025-09-02",{"date":93,"type":94},"2025-09-09","ACTUAL",{"date":96,"type":94},"2024-08-01",{"date":98,"type":80},"2026-08-01",{"name":5,"class":6},1]