[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583423":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":71,"collaborators":27,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":27,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Placebo and TMS",[13,14],"Device: TMS","Other: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"D-serine","ACTIVE_COMPARATOR","D-serine and TMS",[13,20],"Drug: D-serine",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","TMS","Subjects will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device plus placebo.",[16,9],null,{"type":29,"name":16,"description":30,"armGroupLabels":31,"otherNames":27},"DRUG","D-serine, 80 mg\u002Fkg, oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks. Dosing is based on maximal plasticity at 80 mg\u002Fkg, and clinical dose-finding studies demonstrating that doses between 60 - 120 mg\u002Fkg were superior in clinical effectiveness to 30 mg\u002Fkg and were safe.\n\nSubjects will not be randomized into their TMS group and will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device. Subjects will have their TMS protocol\u002Ftreatment determined at the time of consultation according to clinical appropriateness as is the standard of care at the TMS clinic at McLean Hospital.",[16],{"type":6,"name":9,"description":33,"armGroupLabels":34,"otherNames":27},"The placebo is an inactive substance (e.g., lactose or cellulose) packaged to be identical in appearance, taste, and smell to the active study drug. Oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks.",[9],[36],{"name":37,"affiliation":5,"role":38},"Kerry Ressler, MD, PhD","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Joshua C Brown, MD, PhD","CONTACT","617-855-2944","jbrown@mclean.harvard.edu",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Julia Tom, BS, MSN","617-855-2678","jtom1@mgb.org",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.17867,42.39593,{"lat":62,"lon":61},[65,69],{"name":66,"role":42,"phone":67,"phoneExt":27,"email":68},"Dennis Guevara","617-855-2340","dguevara@mclean.harvard.edu",{"name":70,"role":42,"phone":43,"phoneExt":27,"email":44},"Joshua Brown, MD, PhD",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Joshua C. Brown, MD, PhD","Assistant Professor","100583423","phase-1-pharmacologic-augmentation-of-tms-for-depression-with-d-serine-100583423",false,"NCT06876129","Pharmacologic Augmentation of TMS for Depression With D-serine","PAT-DS","Inclusion Criteria:\n\n* Clinical diagnosis of MDD\n* English-speaking\n* Adults aged 18-80\n* Must be able to swallow capsules\n\nRelative contraindications\u002Fpossible exclusion criteria:\n\n* Containing any implanted metal or devices\n* Current or previous seizure history\n* Active substance use that may significantly alter the seizure threshold\n\nAny further safety clearances, and outpatient consultation opinions that are necessitated based on the answers to the screening will be obtained prior to moving forward with the study, as an already established practice within the clinic practice. In addition, any relative contraindications will be further reviewed according to Rossi et al.'s most updated safety guidelines for TMS.\n\nExclusion Criteria:\n\n* Patients with pre-existing renal disease\n* Known allergy to D-serine, or with\n* Patients taking medications with known drug-drug interactions\n* Children\n* Pregnant or breast-feeding women\n\nThe investigators will not include children because prior safety and dosing studies excluded children. Although considered safe for TMS, the investigators will not include pregnant or breast-feeding women on the basis of unknown safety profile of exogenous D-serine for these patients.","ALL","18 Years","80 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","The goal of this study is to test whether combining D-serine with 30 treatments of a) iTBS and b) 18-Hz protocols will enhance clinical outcomes compared to rTMS with placebo (i.e., sugar pill). The investigators hypothesize that NMDA receptor activation via D-serine combined with repeated sessions of rTMS will produce greater clinical outcomes than iTBS with placebo and 18-Hz with placebo.",[93],"Depression","2026-05-13",{"date":96,"type":97},"2026-05-15","ACTUAL",{"date":99,"type":97},"2025-04-01",{"date":101,"type":87},"2027-04-01",{"name":5,"class":6},1]