[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407167":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":61,"collaborators":35,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":35,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":42,"whyStopped":35,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Morning rTMS treatment","EXPERIMENTAL","Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.",[13],"Device: rTMS therapy",{"label":15,"type":10,"description":11,"interventionNames":16},"Afternoon rTMS treatment",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","rTMS therapy","rTMS treatment parameters will be determined by TMS care providers. Typical TMS settings for MDD involve rTMS applied at 10 Hz with an intensity of 120 % of resting motor threshold. Forty trains of 4 s duration with 11s of trains is typically applied (3000 pulses per day), resulting in approximately 90,000 pulses in a given treatment course.",[15,9],[24,25],"repetitive TMS","repetitive transcranial magnetic stimulation",[27],{"name":28,"affiliation":5,"role":29},"Andrew Krystal, MD, MS","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Katherine Scangos, MD, PhD","CONTACT","415-476-7439",null,"brainstim@ucsf.edu",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Rebecca Martinez, MS","rebecca.martinez@ucsf.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","San Francisco","California","94143","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.41942,37.77493,{"lat":52,"lon":51},[55,57,59,60],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":56},"trdepression@ucsf.edu",{"name":38,"role":33,"phone":58,"phoneExt":35,"email":39},"415- 514-6489",{"name":32,"role":29,"phone":35,"phoneExt":35,"email":35},{"name":28,"role":29,"phone":35,"phoneExt":35,"email":35},{"type":62,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100407167","biomarkers-of-depression-and-treatment-response-100407167",false,"NCT04581902","Biomarkers of Depression and Treatment Response","SUNSET","Inclusion Criteria:\n\n* Age 18-70\n* Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.\n* Has Montgomery-Asberg Depressive Rating Scale (MADRS) of \\> 19 at baseline, corresponding with moderate to severe depression.\n* Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.\n* If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which pre-treatment and post-treatment scans are taken.\n* Willing and able to undergo non-invasive brain stimulation\n* Willing and able to attend research visits for approximately 8 weeks\n* Willing and able to provide informed consent\n* Ability to speak and read English\n\nExclusion Criteria:\n\n* Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.\n* Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.\n* Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.\n* Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.\n* Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID\n* History of seizures\n* Implantable hardware not compatible with MRI or with the study\n* Inability to comply with study daily visits\n* Women who are pregnant, plan to become pregnant, or breast feeding\n* Inability to speak and\u002For read English\n* Inability to give consent\n* Any active suicidal intent or plan during the current depressive episode, as determined by a score of 3 on Question #9 of Beck's Depression Inventory (scores reviewed daily by study team members versed in scoring clinical scales), or as by a subjective determination by a study clinician during any study visit.","ALL","18 Years","70 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.",[81],"Depressive Disorder, Major",[83,84,85,86,87,88],"transcranial magnetic stimulation","depression","biomarker","TMS","neuroimaging","rTMS","2026-01-28",{"date":91,"type":92},"2026-01-30","ACTUAL",{"date":94,"type":92},"2020-12-01",{"date":96,"type":75},"2027-09",{"name":5,"class":6},1]