[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652099":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":49,"studyPopulation":49,"armGroups":55,"interventions":68,"overallOfficials":49,"centralContacts":78,"locations":84,"responsibleParty":99,"collaborators":49,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":49,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":49,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":86,"whyStopped":49,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Military Hospital 175","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Change in 17-Item Hamilton Depression Rating Scale (HAM-D17) Score From Baseline to End of Treatment","Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17). The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. The primary outcome is the change in HAM-D17 total score from baseline (T0) to the end-of-treatment assessment (T4).","Baseline (T0) and 24-72 hours after the final treatment session (T4)",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"Treatment Response Based on HAM-D17","Treatment response is defined as a reduction of at least 50% in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score from baseline.",{"measure":18,"description":19,"timeFrame":20},"Remission Based on HAM-D17","Remission is defined as a 17-item Hamilton Depression Rating Scale (HAM-D17) total score of 7 or less at the end of treatment.","End of treatment (T4), assessed 24-72 hours after the final treatment session",{"measure":22,"description":23,"timeFrame":12},"Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)","Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change in PSQI global score from baseline to the end of treatment will be evaluated.",{"measure":25,"description":26,"timeFrame":12},"Change in Quality of Life Assessed by the WHOQOL-BREF","Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which evaluates four domains: physical health, psychological health, social relationships, and environment. Each domain score is transformed to a 0-100 scale, with higher scores indicating better quality of life. Change in each domain score from baseline to the end-of-treatment assessment will be evaluated.",{"measure":28,"description":29,"timeFrame":12},"Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)","Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change in MoCA total score from baseline to the end of treatment will be evaluated.",{"measure":31,"description":32,"timeFrame":12},"Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)","Cognitive function is assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change in MMSE total score from baseline to the end of treatment will be evaluated.",{"measure":34,"description":35,"timeFrame":36},"Incidence of Adverse Events and Serious Adverse Events","Safety and tolerability will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the treatment period. Adverse events potentially associated with iTBS, including headache, scalp discomfort, dizziness, and other reported adverse events, will be recorded. The number and proportion of participants experiencing at least one AE or SAE will be summarized by treatment group.","From the first treatment session through the end-of-treatment assessment (T4)",[38,41],{"measure":39,"description":40,"timeFrame":12},"Change in Individual Alpha Frequency (IAF)","Individual alpha frequency (IAF) will be derived from resting-state electroencephalography (EEG). Change in IAF from baseline to the post-treatment neurophysiological assessment will be evaluated as an exploratory neurophysiological outcome.",{"measure":42,"description":43,"timeFrame":12},"Change in TMS-EEG TMS-Evoked Potential Amplitudes (N45, P60, and N100)","Transcranial magnetic stimulation-electroencephalography (TMS-EEG) will be used to assess neurophysiological changes. TMS-evoked potential amplitudes, including N45, P60, and N100, will be measured. Changes in N45, P60, and N100 amplitudes from baseline (T0) to the end-of-treatment assessment (T4) will be evaluated as exploratory neurophysiological outcomes.",{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":49,"timePerspective":49,"maskingInfo":50},"RANDOMIZED","PARALLEL","Participants with major depressive disorder are randomly assigned in a 1:1 ratio to one of two parallel active-treatment groups: accelerated intermittent theta burst stimulation (iTBS) or standard iTBS.","TREATMENT",null,{"masking":51,"maskingDescription":52,"whoMasked":53},"SINGLE","Outcome assessors will be blinded to treatment allocation. Participants and personnel administering the intervention will not be blinded because of differences in the treatment schedules. Participants will be instructed not to disclose their treatment allocation or treatment schedule to outcome assessors. Outcome assessors will not have access to randomization or treatment-allocation records.",[54],"OUTCOMES_ASSESSOR",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"Accelerated iTBS","EXPERIMENTAL","Participants receive accelerated intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Treatment is administered at 100% of the resting motor threshold, with 1,200 pulses per session. Participants receive three sessions per treatment day, separated by 30 ± 5-minute intervals, over 15 treatment days, for a total of 45 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.",[61],"Device: Accelerated Intermittent Theta Burst Stimulation",{"label":63,"type":64,"description":65,"interventionNames":66},"Standard iTBS","ACTIVE_COMPARATOR","Participants receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Treatment is administered at 120% of the resting motor threshold, with 600 pulses per session. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.",[67],"Device: Standard Intermittent Theta Burst Stimulation",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":49},"DEVICE","Accelerated Intermittent Theta Burst Stimulation","Intermittent theta burst stimulation (iTBS) is delivered to the left dorsolateral prefrontal cortex using the Beam F3 approach. Stimulation consists of triplet bursts at 50 Hz repeated at 5 Hz, with 2 seconds on and 8 seconds off. Each session consists of 1,200 pulses delivered at 100% of the resting motor threshold. Participants receive three sessions per treatment day, separated by 30 ± 5-minute intervals, over 15 treatment days, for a total of 45 sessions.",[57],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":49},"Standard Intermittent Theta Burst Stimulation","Intermittent theta burst stimulation (iTBS) is delivered to the left dorsolateral prefrontal cortex using the Beam F3 approach. Stimulation consists of triplet bursts at 50 Hz repeated at 5 Hz, with 2 seconds on and 8 seconds off. Each session consists of 600 pulses delivered at 120% of the resting motor threshold. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions.",[63],[79],{"name":80,"role":81,"phone":82,"phoneExt":49,"email":83},"Dang Minh Ly, MD","CONTACT","+84359999741","drminhdang@outlook.com",[85],{"facility":5,"status":86,"city":87,"state":49,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","Ho Chi Minh City","700000","Vietnam","VN",{"type":92,"coordinates":93},"Point",[94,95],106.62965,10.82302,{"lat":95,"lon":94},[98],{"name":80,"role":81,"phone":82,"phoneExt":49,"email":83},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"PRINCIPAL_INVESTIGATOR","Hoang Tien Trong Nghia","Head of Department of Neurology","100652099","accelerated-versus-standard-intermittent-theta-burst-stimulation-for-major-depressive-disorder-100652099",false,"NCT07768397","Accelerated Versus Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder","A Randomized Rater-Blinded Trial Comparing Accelerated and Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Right-handed.\n* Diagnosis of major depressive disorder according to ICD-10 criteria (F32 or F33), confirmed by a psychiatrist.\n* 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 at screening\u002Fbaseline.\n* Able and willing to provide written informed consent and comply with essential study procedures.\n* Participants may be psychotropic-medication naïve or may be receiving psychotropic medication. Participants currently receiving psychotropic medication must have maintained the same medication(s) and dose(s) for at least 2 weeks before randomization; for fluoxetine, the required stable period is at least 4 weeks.\n\nExclusion Criteria:\n\n* Intracranial or head\u002Fneck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.\n* Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.\n* Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and\u002For free T4 levels.\n* Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.\n* History of epilepsy or seizures, except febrile seizures in childhood.\n* Bipolar disorder.\n* Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders.\n* Acute suicide risk, defined as a score ≥3 on item 3 of the HAM-D17 or clear suicidal ideation or behavior.\n* Alcohol or substance abuse or dependence within the previous 6 months.\n* A medical condition associated with a high seizure risk or a history of cranial surgery.\n* Current use of medication judged by the screening physician to substantially increase seizure risk, or rapid reduction\u002Fdiscontinuation of benzodiazepines, antiseizure medications, or other centrally acting medications associated with withdrawal or increased seizure risk.\n* Serum vitamin D level \\\u003C20 ng\u002FmL that has not been adequately corrected.\n* Elevated C-reactive protein associated with clinically significant acute infection or acute inflammatory illness that, in the investigator's judgment, may affect participant safety or study outcome assessment.\n* Pregnant or breastfeeding.\n* Unable to understand or complete essential study procedures. Participants with potentially reversible temporary exclusion conditions may be rescreened once the condition has been adequately corrected or clinically stabilized.","ALL","18 Years","65 Years",{"count":114,"type":115},80,"ESTIMATED","INTERVENTIONAL",[118],"NA","This randomized, rater-blinded clinical trial aims to compare the effectiveness, safety, and tolerability of accelerated intermittent theta burst stimulation (iTBS) with standard iTBS in adults with major depressive disorder (MDD).\n\nParticipants will be randomly assigned in a 1:1 ratio to receive either accelerated or standard iTBS targeting the left dorsolateral prefrontal cortex. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. The accelerated iTBS group will receive 45 treatment sessions over approximately 15 treatment days, while the standard iTBS group will receive 20 treatment sessions over 4 weeks.\n\nThe primary objective is to compare changes in depressive symptom severity, measured using the 17-item Hamilton Depression Rating Scale (HAM-D17), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, sleep quality, quality of life, cognitive measures, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).",[121],"Major Depressive Disorder",[123,124,125,57,121],"Intermittent Theta Burst Stimulation","iTBS","Transcranial Magnetic Stimulation","2026-09-03",{"date":128,"type":129},"2026-09-09","ACTUAL",{"date":131,"type":129},"2026-08-27",{"date":133,"type":115},"2028-06",{"name":5,"class":6},1]