[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373482":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":59,"collaborators":28,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":28,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":28,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"The Royal Ottawa Mental Health Centre","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Unilateral TBS","ACTIVE_COMPARATOR","Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).",[13],"Device: Theta burst stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Bilateral TBS","Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Maintenance Phase: Flexible","The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x\u002Fweek) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Theta burst stimulation","Cool B70 coil (left DLPFC) and Cool B65 active\u002Fplacebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A\u002FS, Farum, Denmark)",[15,19,9],null,[30],{"name":31,"affiliation":5,"role":32},"Sara Tremblay, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Stacey Shim, MSc","CONTACT","613-722-6521","6356","stacey.shim@theroyal.ca",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Ottawa","Ontario","K1Z 7K4","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-75.69812,45.41117,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":37,"phoneExt":57,"email":58},"Sara Tremblay","6227","Sara.Tremblay@theroyal.ca",{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100373482","comparing-uni--and-bi-lateral-tbs-in-major-depression-100373482",false,"NCT04142996","Comparing Uni- and Bi-lateral TBS in Major Depression","A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression","Inclusion Criteria:\n\n1. voluntary and competent to consent to study,\n2. female or male aged 18 years old or older,\n3. can speak and read English and\u002For French\n4. primary and\u002For predominant diagnosis of major depressive episode without psychotic features in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),\n5. depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,\n6. moderate symptoms in the current depressive episode as indexed by a score of at least 15 at the 17-item Hamilton Rating Scale for Depression (HRSD-17),\n7. have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,\n8. are able to adhere to treatment schedule,\n9. have received a stable psychiatric medication (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,\n10. have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if are aged ≥ 65.\n\nExclusion Criteria:\n\n1. current or past (\\\u003C 3 months) substance (excluding caffeine or nicotine) or alcohol abuse\u002Fdependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion\n2. current use of illegal substances or recreational cannabis\n3. have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),\n4. organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician\n5. acute suicidality or threat to life from self-neglect,\n6. are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment,\n7. have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),\n8. unwilling to maintain current antidepressant regimen,\n9. are taking more than 1 mg of lorazepam or equivalent,\n10. any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,\n11. have failed a course of electroconvulsive therapy (ECT) within the current depressive episode due to the lower likelihood of response to rTMS.If they have had failed ECT in the past, this does not exclude them","ALL","18 Years",{"count":71,"type":72},256,"ESTIMATED","INTERVENTIONAL",[75],"NA","Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.",[78],"Major Depressive Episode","2023-11-28",{"date":81,"type":82},"2023-12-04","ACTUAL",{"date":84,"type":82},"2019-12-12",{"date":86,"type":72},"2026-09",{"name":5,"class":6},1]