[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07161700":3,"trial-entities:NCT07161700":273,"trial-summary:NCT07161700":277},{"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":21,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":66,"locations":69,"central_contacts":265,"overall_officials":266,"references":271,"see_also_links":272},"NCT07161700","SPT-300-2024-204","An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)","A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress","ENROLLING_BY_INVITATION","2027-05","2026-07","2026-07-13","2025-09-02","Seaport Therapeutics","INDUSTRY",false,"This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.",null,[19,20],"Major Depressive Disorder (MDD)","Major Depressive Disorder With Anxious Distress",[22,23,24,25,26,27,28,29,30,31,32,33],"Major Depressive Disorder","Depressive Disorder","Depression","Anxiety","Mood Disorders","SPT-300","LYT-300","GlyphAllo","Glyph Allopregnanolone","BUOY-1 OLE Study","Anxious Distress","Open Label Extension Study","INTERVENTIONAL","TREATMENT",[37],"PHASE2",{"count":39,"type":40},360,"ESTIMATED",[42],{"type":43,"name":27,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","A prodrug of allopregnanolone, a small molecule drug",[27],[28,29,30],[48],{"measure":49,"description":50,"timeFrame":51},"Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures","Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.","Up to Day 49",[],"ALL","18 Years","66 Years",{"inclusion":57,"exclusion":61,"raw_text":65},[58,59,60],"Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \\[Day 42\\] of Study SPT-300-2024-203 \\[BUOY-1 Study\\]).","Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment.","Participant is willing and able to refrain from the use of drugs of abuse.",[62,63,64],"Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.","Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study).","Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.","Inclusion Criteria:\n\n* Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \\[Day 42\\] of Study SPT-300-2024-203 \\[BUOY-1 Study\\]).\n* Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment.\n* Participant is willing and able to refrain from the use of drugs of abuse.\n\nExclusion Criteria:\n\n* Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.\n* Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study).\n* Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.",[67,68],"ADULT","OLDER_ADULT",[70,79,85,91,98,105,111,118,125,132,137,143,150,156,163,170,176,183,189,192,195,198,206,212,219,222,228,234,240,246,252,259],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Seaport Investigator Site","Chino","California","91710","United States",{"lat":77,"lon":78},34.01223,-117.68894,{"facility":71,"city":80,"state":73,"zip":81,"country":75,"geoPoint":82},"Garden Grove","92845-2506",{"lat":83,"lon":84},33.77391,-117.94145,{"facility":71,"city":86,"state":73,"zip":87,"country":75,"geoPoint":88},"Glendale","91206",{"lat":89,"lon":90},34.14251,-118.25508,{"facility":71,"city":92,"state":93,"zip":94,"country":75,"geoPoint":95},"West Palm Beach","Florida","33407",{"lat":96,"lon":97},26.71534,-80.05337,{"facility":71,"city":99,"state":100,"zip":101,"country":75,"geoPoint":102},"Atlanta","Georgia","30328",{"lat":103,"lon":104},33.749,-84.38798,{"facility":71,"city":106,"state":100,"zip":107,"country":75,"geoPoint":108},"Decatur","30030",{"lat":109,"lon":110},33.77483,-84.29631,{"facility":71,"city":112,"state":113,"zip":114,"country":75,"geoPoint":115},"Boston","Massachusetts","02116",{"lat":116,"lon":117},42.35843,-71.05977,{"facility":71,"city":119,"state":120,"zip":121,"country":75,"geoPoint":122},"St Louis","Missouri","63141",{"lat":123,"lon":124},38.62727,-90.19789,{"facility":71,"city":126,"state":127,"zip":128,"country":75,"geoPoint":129},"Brooklyn","New York","11235",{"lat":130,"lon":131},40.6501,-73.94958,{"facility":71,"city":127,"state":127,"zip":133,"country":75,"geoPoint":134},"10029",{"lat":135,"lon":136},40.71427,-74.00597,{"facility":71,"city":138,"state":127,"zip":139,"country":75,"geoPoint":140},"Staten Island","10314",{"lat":141,"lon":142},40.56233,-74.13986,{"facility":71,"city":144,"state":145,"zip":146,"country":75,"geoPoint":147},"Independence","Ohio","44131",{"lat":148,"lon":149},41.36866,-81.6379,{"facility":71,"city":151,"state":145,"zip":152,"country":75,"geoPoint":153},"North Canton","44720",{"lat":154,"lon":155},40.87589,-81.40234,{"facility":71,"city":157,"state":158,"zip":159,"country":75,"geoPoint":160},"Irving","Texas","75062",{"lat":161,"lon":162},32.81402,-96.94889,{"facility":71,"city":164,"zip":165,"country":166,"geoPoint":167},"Plovdiv","4004","Bulgaria",{"lat":168,"lon":169},42.15387,24.75001,{"facility":71,"city":171,"zip":172,"country":166,"geoPoint":173},"Sofia","1000",{"lat":174,"lon":175},42.69751,23.32415,{"facility":71,"city":177,"zip":178,"country":179,"geoPoint":180},"Brno","602 00","Czechia",{"lat":181,"lon":182},49.19522,16.60796,{"facility":71,"city":184,"zip":185,"country":179,"geoPoint":186},"Prague","100 00",{"lat":187,"lon":188},50.08804,14.42076,{"facility":71,"city":184,"zip":190,"country":179,"geoPoint":191},"110 00",{"lat":187,"lon":188},{"facility":71,"city":184,"zip":193,"country":179,"geoPoint":194},"160 00",{"lat":187,"lon":188},{"facility":71,"city":184,"zip":196,"country":179,"geoPoint":197},"186 00",{"lat":187,"lon":188},{"facility":71,"city":199,"state":200,"zip":201,"country":202,"geoPoint":203},"Schwerin","Mecklenburg-Vorpommern","19053","Germany",{"lat":204,"lon":205},53.62937,11.41316,{"facility":71,"city":207,"zip":208,"country":202,"geoPoint":209},"Chemnitz","09111",{"lat":210,"lon":211},50.8357,12.92922,{"facility":71,"city":213,"zip":214,"country":215,"geoPoint":216},"Bialystok","15-404","Poland",{"lat":217,"lon":218},53.13333,23.16433,{"facility":71,"city":213,"zip":220,"country":215,"geoPoint":221},"15-464",{"lat":217,"lon":218},{"facility":71,"city":223,"zip":224,"country":215,"geoPoint":225},"Bydgoszcz","85-080",{"lat":226,"lon":227},53.1235,18.00762,{"facility":71,"city":229,"zip":230,"country":215,"geoPoint":231},"Gdansk","80-438",{"lat":232,"lon":233},54.35227,18.64912,{"facility":71,"city":235,"zip":236,"country":215,"geoPoint":237},"Leszno","64-100",{"lat":238,"lon":239},51.84034,16.57494,{"facility":71,"city":241,"zip":242,"country":215,"geoPoint":243},"Poznan","60-744",{"lat":244,"lon":245},52.40692,16.92993,{"facility":71,"city":247,"zip":248,"country":215,"geoPoint":249},"Tuszyn","95-080",{"lat":250,"lon":251},51.60949,19.53009,{"facility":71,"city":253,"zip":254,"country":255,"geoPoint":256},"Rimavská Sobota","979 01","Slovakia",{"lat":257,"lon":258},48.38284,20.02239,{"facility":71,"city":260,"zip":261,"country":255,"geoPoint":262},"Vranov nad Topľou","09301",{"lat":263,"lon":264},48.88836,21.68479,[],[267],{"name":268,"affiliation":269,"role":270},"David Walling, Ph.D.","Collaborative Neuroscience Research - Garden Grove","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":274,"biomarkers":276},[275],"Unipolar Depression",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]