NCT07161700

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)

A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Seaport Therapeutics · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder (MDD)
• Major Depressive Disorder With Anxious Distress

Interventions

Type	Name	Description
DRUG	SPT-300	A prodrug of allopregnanolone, a small molecule drug

Timeline

• Start date: 2025-09-02
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-09-09
• Last updated: 2026-03-24

Locations

29 sites across 6 countries: United States, Bulgaria, Czechia, Germany, Poland, Slovakia

Regulatory

• FDA-regulated drug study