[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575566":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":43,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":60,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":60,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":45,"whyStopped":60,"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},"Intervention Group","EXPERIMENTAL","4-weeks of exercise (moderate-to-vigorous intensity) followed by 6 weeks of iTBS combined with exercise.",[13],"Device: Theta burst stimulation",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard Group","Standard care of 4 weeks of stable treatment (i.e. no changes to antidepressant regimen or physical activity) followed by 6 weeks of iTBS alone.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Theta burst stimulation","Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A\u002FS, Farum, Denmark)",[9,15],[25],"rTMS",[27],{"name":28,"affiliation":29,"role":30},"Sara Tremblay, PhD","Royal Ottawa Mental Health Centre","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Stacey Shim, MSc","CONTACT","613-722-6521","6356","stacey.shim@theroyal.ca",{"name":39,"role":34,"phone":40,"phoneExt":41,"email":42},"Emma Cummings, BSc","6137226521","6586","emma.cummings@theroyal.ca",[44],{"facility":29,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Ottawa","Ontario","k1z 7k4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-75.69812,45.41117,{"lat":55,"lon":54},[58],{"name":59,"role":34,"phone":40,"phoneExt":60,"email":37},"Stacey Shim",null,{"type":30,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Sara Tremblay","Scientist",[65],{"name":66,"class":6},"University of Ottawa","100575566","feasibility-trial-of-exercise-as-a-priming-strategy-for-rtms-treatment-in-difficult-to-treat-depression-100575566",false,"NCT06773949","Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression","Randomized Trial Assessing the Feasibility of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression","Inclusion Criteria:\n\n1. Are between 18-75 years old.\n2. Able to provide voluntary informed consent.\n3. Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5.\n4. Depressive symptoms have not improved after ≥ 1 adequate antidepressant trial in the current episode (i.e., difficult-to-treat MDD), based on the Antidepressant Treatment History Form (ATHF).\n5. Baseline score of ≥15 on the HRSD-17.\n6. No change in psychotropic medications or psychotherapy regimen at least 4 weeks prior to entering the trial\n7. Physically inactive as per the International Physical Activity Questionnaire - Short Form (IPAQ-SF).\n8. Able to engage in structured exercise as per the Get Active Questionnaire (GAQ).\n9. Able to adhere to the proposed treatment schedule.\n\nExclusion Criteria:\n\n1. Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.\n2. Current or past (\\\u003C3 months) substance (excluding caffeine or nicotine) or alcohol abuse\u002Fdependence, as defined in DSM-5 criteria.\n3. Current use of illegal substances.\n4. Current use of cannabis.\n5. Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction).\n6. Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician.\n7. Acute suicidality or threat to life from self-neglect.\n8. Pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment.\n9. Contraindication for TMS and MRI (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker), confirmed by TMS Adult Safety Scale (TASS) and MRI pre-screener.\n10. Unwilling to maintain current psychotropic medication and\u002For psychotherapy regimen for the four weeks prior to and for the duration of the study.\n11. Taking more than 1 mg\u002Fday of lorazepam or equivalent.\n12. Any other condition that, in the opinion of the investigators which would adversely affect the participant's ability to complete the study.\n13. Physically active: performing exercise and\u002For physical activity levels meeting the cut-off for \"minimally active\" on the IPAQ-SF.","ALL","18 Years","75 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x\u002Fweek, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.",[85,86],"Major Depressive Disorder (MDD)","Treatment Resistant Depression (TRD)",[88,25,89,90],"iTBS","Exercise","Physical inactivity","2025-12-09",{"date":93,"type":94},"2025-12-17","ACTUAL",{"date":96,"type":79},"2025-12-15",{"date":98,"type":79},"2027-01-31",{"name":5,"class":6},1]