Clinical Trial

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)

Enrolling by Invitation Phase 2
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-09-02; most recent amendment 2026-07-09.
Status change: Recruiting → Enrolling by Invitation 2025-09-29
Trial Details
NCT Number NCT07161700
Lead Sponsor Seaport Therapeutics
Collaborators: Premier Research
Conditions Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress
Enrollment 360 participants
Start Date 2025-09-02
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-13