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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)

NCT07161700 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

SPT-300

A prodrug of allopregnanolone, a small molecule drug

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Seaport Therapeutics

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT07161700 on ClinicalTrials.gov