[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637249":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":53,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Accelerated iTBS","EXPERIMENTAL","Participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) administered over five consecutive days, with four sessions per day (20 sessions total). Participants with partial clinical response may receive an additional 10 sessions.",[13],"Device: Accelerated Intermittent Theta Burst Stimulation (iTBS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Accelerated Intermittent Theta Burst Stimulation (iTBS)","Accelerated intermittent theta burst stimulation (iTBS) is administered bilaterally to the dorsomedial prefrontal cortex using a double-cone coil, targeting the stimulation site based on anatomical landmarks. Treatment is delivered over five consecutive days with four sessions per day (total of 20 sessions). Each session consists of 600 pulses per hemisphere (1200 pulses total) at an intensity of 120% of the individual motor threshold. Participants with partial response may receive an additional 10 sessions.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Cana Aksoy Poyraz, Prof. Dr.","STUDY_CHAIR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Merve Rana Altunel Ülkü, MD","CONTACT","+90 506 303 10 68","ranaltunel@gmail.com",[32],{"facility":5,"status":33,"city":34,"state":20,"zip":35,"country":36,"countryCode":20,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Istanbul","34000","Turkey (Türkiye)",{"type":38,"coordinates":39},"Point",[40,41],28.94966,41.01384,{"lat":41,"lon":40},[44,46,49,51],{"name":45,"role":28,"phone":29,"phoneExt":20,"email":30},"Merve rANA Altunel Ülkü, MD",{"name":23,"role":28,"phone":47,"phoneExt":20,"email":48},"+90 532 715 95 04","aksoycana@gmail.com",{"name":27,"role":50,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":23,"role":52,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":50,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Merve Rana Altunel","Principle Investigator","100637249","accelerated-itbs-for-major-depression-100637249",false,"NCT07603804","Accelerated iTBS for Major Depression","Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder","AIM-D","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of Major Depressive Disorder according to DSM-5 criteria\n* Inadequate response to at least one adequate antidepressant treatment trial\n* Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline\n* Stable dose of antidepressant medication for at least 4 weeks prior to study entry\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression\n* Current substance use disorder\n* Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)\n* History of epileptic seizures\n* Severe head trauma\n* Presence of metal implants in the head or neck region\n* Cochlear implants\n* Cardiac pacemaker or implanted electronic devices\n* History of deep brain stimulation or vagus nerve stimulation\n* Previous neurosurgical procedures\n* Pregnancy or breastfeeding\n* Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)\n* Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)\n* Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)\n* Recent surgery or acute infection\n* Active suicidal crisis, severe agitation, or inability to comply with study procedures","ALL","18 Years","65 Years",{"count":68,"type":69},35,"ESTIMATED","INTERVENTIONAL",[72],"NA","Major depressive disorder (MDD) is a common and disabling psychiatric condition, and many patients do not achieve adequate response to standard antidepressant treatments. Accelerated intermittent theta burst stimulation (iTBS) is a promising neuromodulation approach that may provide rapid antidepressant effects. This prospective interventional study aims to evaluate the clinical effectiveness of accelerated bilateral dorsomedial prefrontal cortex iTBS in patients with MDD and to investigate treatment-related changes in neurobiological biomarkers, including cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, and CRP. Associations between biomarker changes and treatment response will also be examined.",[75,76],"Major Depressive Disorder (MDD)","Treatment Resistant Depression (TRD)",[78,79,80,81,82,83,84,85,9,86,87,88,89,90,91],"Major Depressive Disorder","Treatment Resistant Depression","Depression","Transcranial Magnetic Stimulation","TMS","Intermittent Theta Burst Stimulation","iTBS","Accelerated TMS","Dorsomedial Prefrontal Cortex","Biomarkers","Neuroinflammation","BDNF","Cortisol","ACTH","2026-05-21",{"date":94,"type":95},"2026-05-22","ACTUAL",{"date":97,"type":95},"2026-03-08",{"date":99,"type":69},"2026-12-31",{"name":5,"class":6},1]