[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621368":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":61,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":31,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":31,"overallStatus":83,"whyStopped":31,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental target a-iTBS treatment group","EXPERIMENTAL","Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.",[13],"Device: Experimental target a-iTBS treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional target a-iTBS treatment group","Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.",[18],"Device: Conventional target a-iTBS treatment",{"label":20,"type":21,"description":22,"interventionNames":23},"Sham stimulation treatment group","SHAM_COMPARATOR","Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output. The intervention will use a dedicated sham stimulation coil, which is identical in appearance, operation, and stimulation protocol to the experimental group. This coil is designed to maintain the same auditory and tactile sensations as the active stimulation but is equipped with an electromagnetic shielding structure or an internal reverse coil arrangement to effectively prevent magnetic flux from penetrating the skull, ensuring no actual neuromodulatory effects.",[24],"Device: Sham stimulation treatment",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Experimental target a-iTBS treatment","Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Conventional target a-iTBS treatment","Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Sham stimulation treatment","Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Xinyu Zhou","CONTACT","15823996993","zhouxinyu@cqmu.edu.cn",[47],{"facility":48,"status":31,"city":49,"state":31,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","400016","China","CN",{"type":54,"coordinates":55},"Point",[56,57],106.55771,29.56026,{"lat":57,"lon":56},[60],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},{"type":62,"investigatorFullName":42,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","professor","100621368","efficacy-and-safety-of-accelerated-intermittent-theta-burst-stimulation-a-itbs-in-adolescents-with-depressive-disorder-100621368",false,"NCT07369713","Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder","Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study","Inclusion Criteria:\n\n(1) Age 12 - 18 (2) Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode (3) Score≥40 on the CDRS-R (4) Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study.\n\n\\-\n\nExclusion Criteria:\n\n1. Psychiatric comorbidities other than anxiety disorders\n2. Depression with psychotic symptoms\n3. Young Mania Rating Scale (YMRS) score \\>13\n4. A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma)\n5. Patients currently using anticonvulsants or high-dose benzodiazepines\n6. A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments\n7. A history of alcohol or substance abuse or dependence\n8. Women who are pregnant or breastfeeding\n9. Current high suicide risk\n10. Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery\n11. Contraindications to MRI -","ALL","12 Years","18 Years",{"count":75,"type":76},45,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.",[82],"Depression - Major Depressive Disorder","NOT_YET_RECRUITING","2026-03-02",{"date":86,"type":87},"2026-03-04","ACTUAL",{"date":89,"type":76},"2026-08-01",{"date":91,"type":76},"2028-08-01",{"name":5,"class":6},1]