Clinical Trial

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)

Recruiting Phase 2
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Summary
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
Protocol Amendment History 1 change
notable Trial sites expanded: 45 -> 59 locations 2026-05-20
Trial Details
NCT Number NCT07065240
Lead Sponsor Seaport Therapeutics
Collaborators: Premier Research
Conditions Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress
Enrollment 360 participants
Start Date 2025-06-19
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-13