[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634718":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":29,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"10 Hz tPBM","EXPERIMENTAL",null,[13],"Device: transcranial photobiomodulation",{"label":15,"type":10,"description":11,"interventionNames":16},"40 Hz tPBM",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DEVICE","transcranial photobiomodulation","Participants will receive active transcranial photobiomodulation (tPBM) stimulation at a frequency of 10 Hz. The device delivers near-infrared light targeting the prefrontal cortex. Each treatment session lasts for 20 minutes, administered twice a week for four consecutive weeks (totaling 8 sessions).",[9,15],[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Jia-Shyun Jeng","CONTACT","+886900015031","jscheng2@vghtpe.gov.tw",[30],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Taipei Veterans General Hospital","RECRUITING","Taipei","11217","Taiwan","TW",{"type":38,"coordinates":39},"Point",[40,41],121.52639,25.05306,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":45,"phoneExt":11,"email":28},"+886-900-015-031",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100634718","transcranial-photobiomodulation-tpbm-for-somatic-symptoms-in-treatment-resistant-depression-100634718",false,"NCT07543328","Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression","The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms","Inclusion Criteria:\n\nMust have a current diagnosis of Major Depressive Disorder (MDD).\n\nThe clinical severity must be evaluated by a psychiatrist as moderate or above, defined as a Clinical Global Impression-Severity (CGI-S) score \\> 4 and a 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 18.\n\nMust be currently receiving stable antidepressant treatment for at least four weeks but showing inadequate response (treatment-resistant). This study will be conducted as an add-on therapy.\n\nMust have full behavioral capacity, normal intellectual functioning, and the ability to comprehend and sign the informed consent form.\n\nExclusion Criteria:\n\nIndividuals diagnosed with Bipolar Disorder or Schizophrenia.\n\nIndividuals with current or recent Substance Use Disorder.\n\nHistory of organic brain lesions (e.g., neurodegenerative diseases, epilepsy, stroke) or any medical conditions affecting central nervous system function.\n\nIndividuals with abnormal intellectual functioning based on clinical judgment (e.g., suspected intellectual disability, severe learning difficulties).\n\nIndividuals who are currently pregnant (due to limited evidence regarding the safety of tPBM during pregnancy).\n\nAny other condition that, in the investigator's judgment, would render the participant unable to cooperate, unsuitable for the study, or unwilling to sign the informed consent.","ALL","18 Years","65 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement.\n\nThe specific aims of this study are as follows:\n\nTo evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS).\n\nTo investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms.\n\nTo explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.",[66,67],"Treatment-resistant Depression (TRD)","Major Depression Disorder",[69,67,70],"Photobiomodulation","tPBM","2026-04-24",{"date":73,"type":74},"2026-04-30","ACTUAL",{"date":76,"type":74},"2026-01-06",{"date":78,"type":60},"2027-03-31",{"name":5,"class":6},1]