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)
← catalyst calendarNCT07161700 · readout ≤ 285 d
Sponsored by Seaport Therapeutics (industry) · SPTX — their whole pipeline →. With Premier Research.
Phase
Phase 2
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Treatment
Enrollment
360estimated
Sites
40
Countries
Bulgaria, Czechia, Germany +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-02 | actual | When the study began enrolling |
| Primary completion | May 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Major Depressive Disorder (MDD)
- Major Depressive Disorder With Anxious Distress
Intervention
- Drug: SPT-300 — also filed as LYT-300, GlyphAllo, Glyph Allopregnanolone
Primary outcome
what the primary-completion date above is the date OFSafety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
measured Up to Day 49
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