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)

Part of paid clinical trials in Chino, California.

Sponsor
Seaport Therapeutics
Study ID
NCT07161700
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 66 Years
Healthy Volunteers
Not accepted

Interventions

  • SPT-300 — DRUG
    A prodrug of allopregnanolone, a small molecule drug

Study Details

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.

Key Dates

Start date
Sep 2, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SPT-300
    Participants will receive SPT-300 capsules once daily for 42 days

Primary Outcome Measure

Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures [ Time Frame: Up to Day 49 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Seaport Investigator SiteChinoCalifornia91710-
Seaport Investigator SiteGarden GroveCalifornia92845-2506-
Seaport Investigator SiteGlendaleCalifornia91206-
Seaport Investigator SiteWest Palm BeachFlorida33407-
Seaport Investigator SiteAtlantaGeorgia30328-
Seaport Investigator SiteDecaturGeorgia30030-
Seaport Investigator SiteBostonMassachusetts02116-
Seaport Investigator SiteSt LouisMissouri63141-
Seaport Investigator SiteBrooklynNew York11235-
Seaport Investigator SiteNew YorkNew York10029-
Seaport Investigator SiteStaten IslandNew York10314-
Seaport Investigator SiteNorth CantonOhio44720-
Seaport Investigator SiteIrvingTexas75062-

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