[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643449":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":32,"locations":43,"responsibleParty":61,"collaborators":42,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":42,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":42,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":89,"whyStopped":42,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"The Royal Ottawa Mental Health Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Accelerated iTBS","EXPERIMENTAL","One week of accelerated iTBS and use pre-\u002Fpost-treatment PET\u002FMRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity.",[13],"Device: repetitive Transcranial Magnetic Stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","repetitive Transcranial Magnetic Stimulation","Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily sessions delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm that reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. This study will specifically be administering intermittent TBS (iTBS), which is a novel refinement of conventional rTMS and consists of bursts of 3 stimulations at 50 Hz at theta frequency (5 Hz).",[9],[21,22,23,24],"rTMS","TMS","iTBS","TBS",[26,30],{"name":27,"affiliation":28,"role":29},"Sara Tremblay","The Royal's Institute of Mental Health Research","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Lauri Tuominen",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Stacey Shim","CONTACT","613-722-6521","6356","rtms@theroyal.ca",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},"Emma Cummings","6586",null,[44],{"facility":28,"status":42,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Ottawa","Ontario","K1Z 7K4","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-75.69812,45.41117,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":36,"phoneExt":59,"email":60},"Sara Tremblay, PhD","6227","Sara.Tremblay@theroyal.ca",{"type":29,"investigatorFullName":27,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Principal Investigator","100643449","comparing-outcomes-of-theta-burst-stimulation-in-depression-using-advanced-pet-imaging-100643449",false,"NCT07620288","Comparing Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Measuring Neuroplasticity Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Inclusion Criteria\n\nFor inclusion in the study, participants must fulfill all the following criteria:\n\n1. 18 to 55 years old.\n2. Competent to provide voluntary informed consent.\n3. English comprehension and verbal communication (participants must be able to both understand and speak English sufficiently to follow study procedures and be understood by study personnel\n4. Referred by their treating physician.\n5. Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode.\n6. Symptoms of MDD have not improved after ≥ 1 adequate antidepressant medication trial in the current depressive episode29.\n7. Baseline score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).\n8. Maintained a stable treatment regimen for at least four weeks prior to entering the study, defined as being on a stable antidepressant regimen, a stable psychotherapy regimen, both, or neither (i.e., no treatment), with no changes during this period.\n\nExclusion Criteria\n\nParticipants fulfilling any of the following criteria will be excluded from the study:\n\n1. Any comorbid mental health disorders (including, but not limited to lifetime history of psychotic disorders, OCD, and\u002For bipolar I or II disorder) with the exception of anxiety\u002Fpanic disorders, posttraumatic stress disorder and ADHD\n2. Current or past (\\\u003C 3 months) substance (including nicotine) or alcohol abuse\u002Fdependence, as defined in DSM-5 criteria.\n3. Positive urine test for illegal substances, cannabis, or cotinine.\n4. Significant unstable medical or neurologic illness confirmed by medical history (e.g. uncontrolled diabetes, or renal dysfunction).\n5. Breastfeeding or pregnant (confirmed via urine test).\n6. BMI \\> 30 or BMI \\\u003C 18.\n7. Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker).\n8. Contraindication for MRI (e.g. metallic implant, claustrophobia).\n9. Have received a cumulative radioactivity dose \\> 15.2mSv during the last 12 months.\n10. Have active malignancies (due to high chance of undergoing radiation therapy).\n11. Suicide attempt in the past three months and\u002For active suicidal intent.\n12. Failed (non-response) course of ECT or rTMS treatment in the current depressive episode.\n13. Benzodiazepine or lithium use. Other psychotropic medications (e.g. ADHD medications) are permitted, if stable in the 4 weeks prior to and during the treatment course)\n14. Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study.","ALL","18 Years","55 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-\u002Fpost-treatment PET\u002FMRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine \\[¹⁸F\\]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.",[81,82,83,84],"Depression","Depression - Major Depressive Disorder","Depressive Episode","Major Depressive Disorder (MDD)",[86,23,87,21,88],"PET","accelerated iTBS","MRI","NOT_YET_RECRUITING","2026-06-05",{"date":92,"type":93},"2026-06-09","ACTUAL",{"date":95,"type":75},"2026-08-01",{"date":97,"type":75},"2028-07-30",{"name":5,"class":6},1]