A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
← catalyst calendarNCT07065240 · readout ≤ 224 d
Sponsored by Seaport Therapeutics (industry) · SPTX — their whole pipeline →. With Premier Research.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
360estimated
Sites
62
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 | 2025-06-19 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-15 | 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
Interventions
- Drug: SPT-300 — also filed as LYT-300, GlyphAllo, Glyph Allopregnanolone
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score
measured Baseline (Day 0) to Day 42
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