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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)

NCT07065240 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Seaport Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Walling, Ph.D. · Collaborative Neuroscience Research - Garden Grove

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07065240 on ClinicalTrials.gov