[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07210255":3,"trial-entities:NCT07210255":151,"trial-summary:NCT07210255":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":48,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":64,"central_contacts":137,"overall_officials":138,"references":139,"see_also_links":150},"NCT07210255","CLN-0108","SAINT in Postpartum Depression (PPD)","A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression","RECRUITING","2029-10-31","2026-05","2026-05-14","2025-11-01","Magnus Medical","INDUSTRY",true,"This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.\n\nIt will enroll 192 women within 12 months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.","SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.\n\nThis is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in women with PPD. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves.\n\nThis study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable.\n\nThere are two phases in this study:\n\n1. A blinded phase where participants will be randomized to receive either 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo).\n2. After the blinded phase, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they may be eligible to receive 1 course of active SAINT treatment. (5 days).\n\nTotal study duration for each participant is approximately 7.5 months.",[19],"Postpartum Depression (PPD)",[21,22,23,24,25,26,27],"SAINT","Stanford Accelerated Intelligent Neuromodulation Therapy","Repetitive Transcranial Magnetic Stimulation (rTMS)","Intermittent Theta Burst Stimulation (iTBS)","Noninvasive Brain Stimulation","Postpartum depression","Neuromodulation","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},192,"ESTIMATED",[36,44],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DEVICE","SAINT Neuromodulation System","SAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A\u002FP coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions 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 administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system.",[41],"Active SAINT Stimulation",[43,21],"SAINT NMS",{"type":37,"name":45,"description":46,"armGroupLabels":47},"Sham SAINT Stimulation","Sham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A\u002FP coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered.",[45],[49],{"measure":50,"description":51,"timeFrame":52},"Montgomery-Asberg Depression Rating Scale (MADRS)","The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.","Baseline and 5 days post-acute treatment",[],"FEMALE","18 Years","45 Years",false,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion Criteria:\n\n1. Reproductive Women ages 18-45 at the time of consent.\n2. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.\n3. 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.\n4. If currently taking an antidepressant medication and\u002For receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.\n5. Severe depression as measured by MADRS ≥20 at screening.\n6. A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.\n7. Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.\n8. Agree to use effective contraception in the postpartum period for the study duration.\n9. Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.\n\nExclusion Criteria:\n\n1. Participant has attempted suicide in the last 6 months and\u002For expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.\n2. Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.\n3. Participant has active psychosis per investigator assessment.\n4. Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and\u002For obsessive-compulsive disorder.\n5. Participant has an active eating disorder or substance use disorder in the past 6 months and\u002For has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.\n6. Participant is using any exclusionary medications: high dose of benzodiazepines (\\>2mg lorazepam daily equivalent and\u002For \\>3 times per week) or medications that would interfere with treatment with TMS as per PI or designee discretion.\n7. Participant has a history of untreated or insufficiently treated sleep apnea.\n8. Participant has a history of significant neurologic disease, including developmental disability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure\u002Fepilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.\n9. Any untreated major somatic illness such as hypertension\u002Fcardiovascular disease\u002Fdiabetes\u002Fendocrine disorders etc.\n10. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).\n11. Contraindications to MRI (e.g., ferromagnetic metal in their body).\n12. Currently pregnant.\n13. History of receiving rTMS for any reason, as this may compromise blinding.",[63],"ADULT",[65,87,107,122],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":84},"UMass Chan Medical School","Worcester","Massachusetts","01655","United States",[72,77,81],{"name":73,"role":74,"phone":75,"email":76},"Erin Hanzlik","CONTACT","774.370.8613","erin.hanzlik@umassmemorial.org",{"name":78,"role":74,"phone":79,"email":80},"Sherry Stumpo","508-334-1055","sherry.stumpo@umassmed.edu",{"name":82,"role":83},"Kimberly Yonkers, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},42.26259,-71.80229,{"facility":88,"status":8,"city":89,"state":89,"zip":90,"country":70,"contacts":91,"geoPoint":104},"Icahn School of Medicine at Mount Sinai","New York","10029",[92,96,100,102],{"name":93,"role":74,"phone":94,"email":95},"Francesca Rutherford","646-853-3316","francesca.rutherford@mssm.edu",{"name":97,"role":74,"phone":98,"email":99},"Carolina Jimenez","646-493-1684","Carolina.Jimenez@mountsinai.org",{"name":101,"role":83},"Thalia Robakis, MD, PhD",{"name":103,"role":83},"Veerle Bergink, MD, PhD",{"lat":105,"lon":106},40.71427,-74.00597,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":70,"contacts":112,"geoPoint":119},"The Medical University of South Carolina (MUSC)","Charleston","South Carolina","29425",[113,117],{"name":114,"role":74,"phone":115,"email":116},"Christina Marsicano","843-608-8593","chm275@musc.edu",{"name":118,"role":83},"Connie Guille, MD",{"lat":120,"lon":121},32.77632,-79.93275,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":70,"contacts":127,"geoPoint":134},"University of Texas at Austin, Dell Medical School, Health Discovery Building","Austin","Texas","78712",[128,132],{"name":129,"role":74,"phone":130,"email":131},"Ambreen Rana","512-766-6209","ambreen.rana@austin.utexas.edu",{"name":133,"role":83},"Jeffrey Newport, MD, MS, MDiv",{"lat":135,"lon":136},30.26715,-97.74306,[],[],[140,144,147],{"pmid":141,"type":142,"citation":143},"29415152","BACKGROUND","Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093\u002Fbrain\u002Fawx379. No abstract available.",{"pmid":145,"type":142,"citation":146},"34711062","Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176\u002Fappi.ajp.2021.20101429. Epub 2021 Oct 29.",{"pmid":148,"type":142,"citation":149},"32252538","Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176\u002Fappi.ajp.2019.19070720. Epub 2020 Apr 7.",[],{"nct_id":4,"conditions":152,"biomarkers":154},[153],"Postpartum Depression",[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is a multi-site, randomized study comparing SAINT to a sham treatment in 192 women. Participants will be randomly assigned to receive either the active SAINT treatment or the sham treatment.","completed","SAINT for Postpartum Depression","This study is testing a treatment called SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) for women experiencing postpartum depression (PPD). SAINT is a fast-acting type of repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses to stimulate specific areas of the brain. Researchers want to see if SAINT can reduce depression symptoms more effectively than a sham (inactive) treatment. The study plans to include 192 women, aged 18-45, who are 0-12 months postpartum and have depression that hasn't improved with usual care. The main goal is to measure changes in depression severity after 5 days of treatment using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS).","Participants will be followed for up to 12 months after giving birth. The primary outcome is measured 5 days post-acute treatment.",106,"Participants will receive 10 daily sessions of SAINT or sham stimulation over 5 days. Their depression symptoms will be assessed at the start of the study and 5 days after treatment.","Not stated in the trial record.",[],"v2"]