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)

Part of paid clinical trials in Chino, California.

Sponsor
Seaport Therapeutics
Study ID
NCT07065240
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 19, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPT-300
    Participants will receive SPT-300 capsules once daily for 42 days
  • Placebo Comparator: Placebo
    Participants will receive matching placebo once daily for 42 days

Primary Outcome Measure

Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score [ Time Frame: Baseline (Day 0) to Day 42 ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Seaport Investigator SiteChinoCalifornia91710-
Seaport Investigator SiteGarden GroveCalifornia92845-2506-
Seaport Investigator SiteGlendaleCalifornia91206-
Seaport Investigator SiteSan JoseCalifornia95124-
Seaport Investigator SiteCromwellConnecticut06416-
Seaport Investigator SiteJacksonvilleFlorida32256-
Seaport Investigator SiteLauderhillFlorida33319-
Seaport Investigator SiteOrlandoFlorida32801-
Seaport Investigator SitePalm BayFlorida32905-
Seaport Investigator SiteWest Palm BeachFlorida33407-
Seaport Investigator SiteAtlantaGeorgia30328-
Seaport Investigator SiteDecaturGeorgia30030-
Seaport Investigator SiteMariettaGeorgia30060-
Seaport Investigator SiteBostonMassachusetts02116-
Seaport Investigator SiteBostonMassachusetts02131-
Seaport Investigator SiteRussells MillsMassachusetts02747-
Seaport Investigator SiteSt LouisMissouri63141-
Seaport Investigator SiteBrooklynNew York11235-
Seaport Investigator SiteCedarhurstNew York11516-
Seaport Investigator SiteNew YorkNew York10029-
Seaport Investigator SiteStaten IslandNew York10314-
Seaport Investigator SiteIndependenceOhio44131-
Seaport Investigator SiteNorth CantonOhio44720-
Seaport Investigator SiteAllentownPennsylvania18104-
Seaport Investigator SiteDallasTexas75231-
Seaport Investigator SiteIrvingTexas75062-
Seaport Investigator SiteRichardsonTexas75080-
Seaport Investigator SiteEverettWashington98201-

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