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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)
Sponsor: Seaport Therapeutics
Summary
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.
Official title: A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress
Key Details
Gender
All
Age Range
18 Years - 66 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-09-02
Completion Date
2027-05
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
SPT-300
A prodrug of allopregnanolone, a small molecule drug
Locations (29)
Seaport Investigator Site
Chino, California, United States
Seaport Investigator Site
Garden Grove, California, United States
Seaport Investigator Site
Glendale, California, United States
Seaport Investigator Site
West Palm Beach, Florida, United States
Seaport Investigator Site
Atlanta, Georgia, United States
Seaport Investigator Site
Decatur, Georgia, United States
Seaport Investigator Site
Boston, Massachusetts, United States
Seaport Investigator Site
St Louis, Missouri, United States
Seaport Investigator Site
Brooklyn, New York, United States
Seaport Investigator Site
New York, New York, United States
Seaport Investigator Site
Staten Island, New York, United States
Seaport Investigator Site
North Canton, Ohio, United States
Seaport Investigator Site
Irving, Texas, United States
Seaport Investigator Site
Plovdiv, Bulgaria
Seaport Investigator Site
Sofia, Bulgaria
Seaport Investigator Site
Brno, Czechia
Seaport Investigator Site
Prague, Czechia
Seaport Investigator Site
Prague, Czechia
Seaport Investigator Site
Schwerin, Mecklenburg-Vorpommern, Germany
Seaport Investigator Site
Chemnitz, Germany
Seaport Investigator Site
Bialystok, Poland
Seaport Investigator Site
Bialystok, Poland
Seaport Investigator Site
Bydgoszcz, Poland
Seaport Investigator Site
Gdansk, Poland
Seaport Investigator Site
Leszno, Poland
Seaport Investigator Site
Poznan, Poland
Seaport Investigator Site
Tuszyn, Poland
Seaport Investigator Site
Rimavská Sobota, Slovakia
Seaport Investigator Site
Vranov nad Topľou, Slovakia