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)

PHASE2RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

June 19, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 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

DRUG

Placebo

Placebo for SPT-300

Trial Locations (29)

4004

RECRUITING

Seaport Investigator Site, Plovdiv

10029

RECRUITING

Seaport Investigator Site, New York

10314

RECRUITING

Seaport Investigator Site, Staten Island

11235

RECRUITING

Seaport Investigator Site, Brooklyn

30030

RECRUITING

Seaport Investigator Site, Decatur

30060

RECRUITING

Seaport Investigator Site, Marietta

30328

RECRUITING

Seaport Investigator Site, Atlanta

33407

RECRUITING

Seaport Investigator Site, West Palm Beach

44131

RECRUITING

Seaport Investigator Site, Independence

44720

RECRUITING

Seaport Investigator Site, North Canton

63141

RECRUITING

Seaport Investigator Site, St Louis

75062

RECRUITING

Seaport Investigator Site, Irving

91206

RECRUITING

Seaport Investigator Site, Glendale

91710

RECRUITING

Seaport Investigator Site, Chino

92845-2506

RECRUITING

Seaport Investigator Site, Garden Grove

06416

RECRUITING

Seaport Investigator Site, Cromwell

02116

RECRUITING

Seaport Investigator Site, Boston

02131

RECRUITING

Seaport Investigator Site, Boston

602 00

RECRUITING

Seaport Investigator Site, Brno

301 00

RECRUITING

Seaport Investigator Site, Pilsen

100 00

RECRUITING

Seaport Investigator Site, Prague

160 00

RECRUITING

Seaport Investigator Site, Prague

186 00

RECRUITING

Seaport Investigator Site, Prague

15-404

RECRUITING

Seaport Investigator Site, Bialystok

15-464

RECRUITING

Seaport Investigator Site, Bialystok

85-080

RECRUITING

Seaport Investigator Site, Bydgoszcz

60-744

RECRUITING

Seaport Investigator Site, Poznan

87-100

RECRUITING

Seaport Investigator Site, Torun

95-080

RECRUITING

Seaport Investigator Site, Tuszyn

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Premier Research

OTHER

lead

Seaport Therapeutics

INDUSTRY