NCT07161700View on ClinicalTrials.gov

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)

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

September 2, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Major Depressive Disorder (MDD)Major Depressive Disorder With Anxious Distress
Interventions
DRUG

SPT-300

A prodrug of allopregnanolone, a small molecule drug

Trial Locations (10)

10314

Seaport Investigator Site, Staten Island

11235

Seaport Investigator Site, Brooklyn

30030

Seaport Investigator Site, Decatur

30328

Seaport Investigator Site, Atlanta

44720

Seaport Investigator Site, North Canton

63141

Seaport Investigator Site, St Louis

75062

Seaport Investigator Site, Irving

91206

Seaport Investigator Site, Glendale

91710

Seaport Investigator Site, Chino

02116

Seaport Investigator Site, Boston

Sponsors

Collaborators (1)

Premier Research
All Listed Sponsors
collaborator

Premier Research

OTHER

lead

Seaport Therapeutics

INDUSTRY

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) | Biotech Hunter | Biotech Hunter