[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556310":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":40,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":45,"whyStopped":40,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard SAINT®","ACTIVE_COMPARATOR","10 daily sessions (50 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).",[13],"Device: MagPro X100 edition (MagVenture, Skovlunde, Denmark)",{"label":15,"type":16,"description":17,"interventionNames":18},"Truncated SAINT®","EXPERIMENTAL","5 daily sessions (25 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","MagPro X100 edition (MagVenture, Skovlunde, Denmark)","10 daily sessions (50 total over 5-days) of SAINT® (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).",[9],[26],"Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with Magnus Neuromodulation System (MNS)",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"5 daily sessions (25 total over 5-days) of SAINT® (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).",[15],[26],[32],{"name":33,"affiliation":5,"role":34},"Sean J O'Sullivan, M.D., Ph. D.","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Elyse J Lemke","CONTACT","512-495-5566",null,"elyse.lemke@austin.utexas.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Dell Medical School at University of Texas at Austin","RECRUITING","Austin","Texas","78731","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-97.74306,30.26715,{"lat":55,"lon":54},[58,60,62],{"name":59,"role":38,"phone":39,"phoneExt":40,"email":41},"Elyse Lemke",{"name":40,"role":38,"phone":40,"phoneExt":40,"email":61},"Psychclinicaltrials@austin.utexas.edu",{"name":63,"role":34,"phone":40,"phoneExt":40,"email":40},"Sean J O'Sullivan, MD, PhD",{"type":65,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[67],{"name":68,"class":69},"Magnus Medical","INDUSTRY","100556310","accelerated-intermittent-theta-burst-in-treatment-naive-adolescents-100556310",false,"NCT06523439","Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents","Investigating a Truncated Version of SAINT in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial","SAINT-KID","Inclusion Criteria:\n\n1. Male or Female, between the ages of 14 and 19 at the time of screening.\n2. Able to read, understand, and provide written, dated assent and\u002For consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.\n3. Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).\n4. No prior major depressive episodes (MDEs) as determined by MINI-KID\n5. HAMD-17 score of ≥20 at screening (Visit 1).\n6. Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 4 weeks of antidepressant medication and fewer than 8 psychotherapy sessions in lifetime; willingness to taper medications and stop psychotherapy if recently started and within the window defined above.)\n7. TMS naive.\n8. Access to ongoing psychiatric care before and after completion of the study.\n9. In good general health, as evidenced by medical history.\n10. Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. High-risk for suicide or active suicidal ideation (Suicidal Ideation Questionnaire- Junior \\[SIQ-JR\\] ≥ 31).\n3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (\\>3 on SAPAS; \\>10 on GAD-7)\n4. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)\n5. Current mania or psychosis\n6. Bipolar Affective Disorder and\u002For primary psychotic disorders.\n7. Autism Spectrum disorder or Intellectual Disability\n8. A diagnosis of obsessive-compulsive disorder (OCD)\n9. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.\n10. Urine screening test positive for illicit substances.\n11. Any history of ECT (greater than 8 sessions) without meeting responder criteria\n12. Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).\n13. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure\u002Fepilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.\n14. Untreated or insufficiently treated endocrine disorder.\n15. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)\n16. Contraindications to MRI (ferromagnetic metal in their body).\n17. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.\n18. Depth-adjusted aiTBS treatment dose \\> 65% maximum stimulator output (MSO)\n19. Treatment with another investigational drug or other intervention within the study period.\n20. Any other condition deemed by the PI to interfere with the study or increase risk to the participant.","ALL","14 Years","19 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"NA","This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.\n\nThe main questions this trial aims to answer are:\n\n* Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents?\n* Is SAINT® a feasible option as a first-line treatment for adolescent depression?\n\nResearchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.\n\nAdolescent participants will:\n\n* Remain antidepressant-free throughout the study period of 6-7 weeks.\n* Receive an MRI of their head for precision targeting\n* Receive 5 days of aiTBS (SAINT®)",[89,90,91,92],"Major Depressive Disorder","Depression in Adolescence","Depression","Major Depressive Episode",[94,95,96,97,98,99,100],"Stanford Accelerated Intelligent Neuromodulation Therapy","SAINT","Transcranial Magnetic Stimulation","Accelerated Theta Burst Stimulation","Accelerated Intermittent Theta Burst Stimulation","TMS","TMS in Adolescents","2024-12-06",{"date":103,"type":104},"2024-12-12","ACTUAL",{"date":106,"type":83},"2025-01",{"date":108,"type":83},"2026-09",{"name":5,"class":6},1]