[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657912":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":72,"studyPopulation":72,"armGroups":81,"interventions":94,"overallOfficials":72,"centralContacts":104,"locations":72,"responsibleParty":110,"collaborators":72,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":72,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":139,"whyStopped":72,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":72},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit)","Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit). The MADRS assesses the severity of depressive symptoms, with higher scores indicating greater severity. A greater reduction indicates greater improvement in depressive symptoms","Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)",[14,18,22,26,30,33,36,39,43],{"measure":15,"description":16,"timeFrame":17},"Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate","Proportion of participants with a clinical response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from pre-treatment baseline","Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":19,"description":20,"timeFrame":21},"Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate","Proportion of participants achieving remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 10 or lower.","1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":23,"description":24,"timeFrame":25},"Change From Pre-treatment baseline (Day -1) in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Follow-up Visits","Change in MADRS total score from Pre-treatment baseline (Day -1) to each specified follow-up visit. The MADRS total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms. A greater reduction from baseline indicates greater improvement.","Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":27,"description":28,"timeFrame":29},"Change in the 30-Item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30) Total Score","Change in self-reported depressive symptom severity assessed using the IDS-SR30. Higher scores indicate greater depressive symptom severity. A greater reduction from pre-treatment baseline (Day -1) indicates greater improvement.","Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":31,"description":32,"timeFrame":29},"Change in 17-item Hamilton Depression Rating Scale (HAM-D-17) Total Score","Change in clinician-rated depressive symptom severity assessed using the HAM-D-17. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. A greater reduction from pre-treatment baseline (Day -1) indicates greater improvement.",{"measure":34,"description":35,"timeFrame":17},"Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score","Change in SHAPS total score from baseline to each follow-up visit. The SHAPS is a 14-item self-reported measure of hedonic capacity and anhedonia. Higher scores indicate greater anhedonia, and a reduction from Pre-treatment baseline (Day -1) indicates improvement",{"measure":37,"description":38,"timeFrame":17},"Change in Clinical Global Impression (CGI) Score","The Clinical Global Impression (CGI) will be used to assess overall changes in participants' clinical condition and treatment response throughout the study.",{"measure":40,"description":41,"timeFrame":42},"Change in Pittsburgh Sleep Quality Index (PSQI) Total Score","Change in PSQI total score from baseline to each follow-up visit. The PSQI assesses subjective sleep quality and sleep disturbance. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A reduction from baseline indicates improvement.","Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":44,"description":45,"timeFrame":46},"Change in MATRICS Consensus Cognitive Battery (MCCB) Scores","Change in the MCCB overall composite score and prespecified cognitive-domain scores from baseline. The MCCB assesses processing speed, attention\u002Fvigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Higher scores indicate better cognitive performance.","Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).",[48,52,55,58,62,66],{"measure":49,"description":50,"timeFrame":51},"Incidence of Adverse Events and Serious Adverse Events","Relevant information will be collected through active inquiry, participant self-reports, clinical observation, and necessary medical examinations.","From the first stimulation session on Treatment Day 1 through 8 weeks post-treatment (Week 8; Day 62).",{"measure":53,"description":54,"timeFrame":29},"Emergence or Worsening of Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia-Suicide Severity Rating Scale","Occurrence or worsening of suicidal ideation or suicidal behavior assessed using the Columbia-Suicide Severity Rating Scale. Outcomes include newly emergent or increased suicidal ideation, suicidal intent, suicidal planning, suicidal behavior, or an increased level of suicide risk compared with baseline.",{"measure":56,"description":57,"timeFrame":17},"Emergence or Worsening of Manic Symptoms Assessed by the Young Mania Rating Scale","The Young Mania Rating Scale (YMRS) will be used as a safety measure to monitor the emergence or worsening of manic symptoms during and after treatment. The total score ranges from 0 to 60, with higher scores indicating greater severity of manic symptoms.",{"measure":59,"description":60,"timeFrame":61},"Change in Transcranial Magnetic Stimulation-Evoked Potentials","Change in the amplitude and latency of transcranial magnetic stimulation-evoked electroencephalographic potential components, including the N45 and N100 components, following stimulation of the left dorsolateral prefrontal cortex. These measures assess cortical excitation-inhibition balance and neuroplasticity.","Screening (Day -8), pre-treatment baseline (Day -1), after completion of the tenth stimulation session on treatment Day 3 (Day 3), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), and 4 weeks post-treatment (Week 4; Day 34).",{"measure":63,"description":64,"timeFrame":65},"Change in MRI-Derived Neuroimaging Measures","Changes in prespecified resting-state functional MRI-derived functional connectivity measures from baseline to each post-treatment assessment. These measures will include functional connectivity between the left dorsolateral prefrontal cortex target and the subgenual anterior cingulate cortex (sgACC), functional connectivity within the default mode network (DMN), functional connectivity between the sgACC and the DMN,and functional connectivity between the DLPFC and the DMN.","Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).",{"measure":67,"description":68,"timeFrame":61},"Change in Resting-State Electroencephalography Measures","Changes in prespecified measures derived from resting-state electroencephalography (EEG). These measures will include frontal alpha asymmetry, alpha-band current source density, the aperiodic 1\u002Ff slope, and EEG spectral characteristics. These exploratory measures will be used to evaluate treatment-related changes in electrophysiological activity and their associations with clinical outcomes.",{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":72,"timePerspective":72,"maskingInfo":74},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":75,"maskingDescription":72,"whoMasked":76},"QUADRUPLE",[77,78,79,80],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[82,88],{"label":83,"type":84,"description":85,"interventionNames":86},"Active: Accelerated iTBS","EXPERIMENTAL","Participants in this arm will receive personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex. The treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 pulses total, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval.",[87],"Device: Personalized Functional-Connectivity-Targeted Accelerated iTBS",{"label":89,"type":90,"description":91,"interventionNames":92},"Sham: Accelerated iTBS","SHAM_COMPARATOR","Participants in this arm will receive sham accelerated intermittent theta-burst stimulation using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule. The sham system is designed to match coil positioning, sound, and scalp sensation, while delivering no effective cortical magnetic field.",[93],"Device: Sham Accelerated iTBS",[95,100],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":72},"DEVICE","Personalized Functional-Connectivity-Targeted Accelerated iTBS","Personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation delivered to the left dorsolateral prefrontal cortex. The stimulation target is individualized using resting-state functional MRI. The active treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 total pulses, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval.",[83],{"type":96,"name":101,"description":102,"armGroupLabels":103,"otherNames":72},"Sham Accelerated iTBS","Sham accelerated intermittent theta-burst stimulation delivered using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule as the active intervention. The sham system is designed to match coil positioning, acoustic click, and scalp sensation, while delivering no effective cortical magnetic field.",[89],[105],{"name":106,"role":107,"phone":108,"phoneExt":72,"email":109},"Adam Williamson, PhD","CONTACT","8615026544105","full.field.hammer@gmail.com",{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":72,"oldOrganization":72},"PRINCIPAL_INVESTIGATOR","Gang Wang","Prof.","100657912","personalized-accelerated-itbs-versus-sham-for-major-depressive-disorder-100657912",false,"NCT07843875","Personalized Accelerated iTBS Versus Sham for Major Depressive Disorder","Personalized Functional-Connectivity-Targeted Accelerated Intermittent Theta-Burst Stimulation Versus Sham for Major Depressive Disorder","iTBS-MDD","Inclusion Criteria:\n\n* Aged 22 to 65 years, regardless of sex. Right-handed.\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, confirmed using the Mini International Neuropsychiatric Interview (MINI), version 7.0.The current major depressive episode has lasted for at least 4 weeks.\n* Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 20 or greater at both screening and baseline.\n* Stable depressive symptoms, defined as a difference in MADRS total score between screening and baseline of no more than 20%.\n* Currently medication-free or receiving a stable dose of psychiatric medication for at least 4 weeks before enrollment, with agreement to maintain the same medication regimen through the Week 4 follow-up.\n* Able to provide a complete and verifiable history of previous antidepressant treatments.\n* Eligible to undergo magnetic resonance imaging (MRI).\n* Able to complete all protocol-specified resting-state electroencephalography (EEG) and transcranial magnetic stimulation-electroencephalography (TMS-EEG) assessments.\n* Able to understand and comply with the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Current or previous diagnosis of bipolar disorder, a psychotic disorder, primary obsessive-compulsive disorder, post-traumatic stress disorder, or another psychiatric disorder considered incompatible with study participation.\n* A response of \"yes\" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the current depressive episode; suicidal behavior within the 6 months before screening; or current high suicide risk as determined by the investigator.\n* A change of more than 20% in MADRS total score between screening and baseline.\n* A skull defect or fracture, treatment-resistant epilepsy, brain tumor, stroke, or another serious medical or neurological condition that may affect study participation or safety.\n* A cardiac pacemaker, cochlear implant, MRI-incompatible metallic foreign body, implanted electronic device, claustrophobia, or another contraindication to MRI or transcranial magnetic stimulation.\n* Pregnant or breastfeeding.\n* Participation in another drug or medical-device clinical trial within 1 month before screening.\n* Receipt of electroconvulsive therapy, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, deep brain stimulation, light therapy, or another systematic neuromodulation treatment within 1 month before screening.\n* Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.","ALL","22 Years","65 Years",{"count":126,"type":127},90,"ESTIMATED","INTERVENTIONAL",[130],"NA","This randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). A total of 90 participants will be randomly assigned in a 1:1 ratio to receive either active iTBS or matched sham stimulation. Treatment will be administered over 5 consecutive days, with 10 stimulation sessions per day.\n\nFor each participant, an individualized stimulation target within the left dorsolateral prefrontal cortex will be identified using resting-state functional magnetic resonance imaging (MRI). The primary objective is to compare the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34) between the active and sham groups. Changes in other clinical symptoms, treatment response, remission, and safety will also be assessed during follow-up through 8 weeks after treatment.\n\nMultimodal MRI, resting-state electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG) will be collected at prespecified time points. These measures will be used to explore treatment-related changes in brain function and connectivity and to identify potential neuroimaging and neurophysiological biomarkers associated with clinical improvement and the maintenance of treatment effects.",[133],"Major Depressive Disorder (MDD)",[135,136,137,138],"accelerated iTBS","functional connectivity targeting","DLPFC","personalized neuromodulation","NOT_YET_RECRUITING","2026-09-21",{"date":142,"type":143},"2026-09-28","ACTUAL",{"date":145,"type":127},"2026-09",{"date":147,"type":127},"2027-12-31",{"name":5,"class":6}]