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)
Condition(s) studied
Investigational drug(s) / intervention(s)
SPT-300: A prodrug of allopregnanolone, a small molecule drug
Study 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.
Eligibility
Primary outcome measure(s)
- Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures — Up to Day 49
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.
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Seaport Investigator Site | Chino | California | |
| Seaport Investigator Site | Garden Grove | California | |
| Seaport Investigator Site | Glendale | California | |
| Seaport Investigator Site | San Jose | California | |
| Seaport Investigator Site | Cromwell | Connecticut | |
| Seaport Investigator Site | Lauderhill | Florida | |
| Seaport Investigator Site | Palm Bay | Florida | |
| Seaport Investigator Site | West Palm Beach | Florida | |
| Seaport Investigator Site | Atlanta | Georgia | |
| Seaport Investigator Site | Decatur | Georgia | |
| Seaport Investigator Site | Boston | Massachusetts | |
| Seaport Investigator Site | St Louis | Missouri | |
| Seaport Investigator Site | Brooklyn | New York | |
| Seaport Investigator Site | Cedarhurst | New York | |
| Seaport Investigator Site | New York | New York | |
| Seaport Investigator Site | Staten Island | New York | |
| Seaport Investigator Site | Independence | Ohio | |
| Seaport Investigator Site | North Canton | Ohio | |
| Seaport Investigator Site | Irving | Texas | |
| Seaport Investigator Site | Richardson | Texas | |
| 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 | Prague | Czechia | |
| Seaport Investigator Site | Prague | Czechia | |
| Seaport Investigator Site | Berlin | Brandenburg | |
| Seaport Investigator Site | Schwerin | Mecklenburg-Vorpommern | |
| Seaport Investigator Site | Bad Homburg | Germany | |
| Seaport Investigator Site | Chemnitz | Germany | |
| Seaport Investigator Site | Budapest | Hungary | |
| Seaport Investigator Site | Budapest | Hungary | |
| 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 |
+ 2 more sites — see the full list on the official registry below.
More Seaport Therapeutics trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07161700 on ClinicalTrials.gov ↗ ← All trials in Poland