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Enrolling by invitation NCT07161700

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)

Phase II Interventional Major Depressive Disorder (MDD) Major Depressive Disorder With Anxious Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPT-300.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress. Basic parameters: 18 years — 66 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Czechia, Germany, Poland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

  • Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]).
  • Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
  • Participant is willing and able to refrain from the use of drugs of abuse.

Exclusion criteria

  • Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.
  • Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study).
  • Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Seaport Investigator Site — Chino
  • Seaport Investigator Site — Garden Grove
  • Seaport Investigator Site — Glendale
  • Seaport Investigator Site — West Palm Beach
  • Seaport Investigator Site — Atlanta
  • Seaport Investigator Site — Decatur
  • Seaport Investigator Site — Boston
  • Seaport Investigator Site — St Louis
  • … and 6 more centers
Poland · 7 centers
  • Seaport Investigator Site — Bialystok
  • Seaport Investigator Site — Bialystok
  • Seaport Investigator Site — Bydgoszcz
  • Seaport Investigator Site — Gdansk
  • Seaport Investigator Site — Leszno
  • Seaport Investigator Site — Poznan
  • Seaport Investigator Site — Tuszyn
Czechia · 5 centers
  • Seaport Investigator Site — Brno
  • Seaport Investigator Site — Prague
  • Seaport Investigator Site — Prague
  • Seaport Investigator Site — Prague
  • Seaport Investigator Site — Prague
Bulgaria · 2 centers
  • Seaport Investigator Site — Plovdiv
  • Seaport Investigator Site — Sofia
Germany · 2 centers
  • Seaport Investigator Site — Schwerin
  • Seaport Investigator Site — Chemnitz
Slovakia · 2 centers
  • Seaport Investigator Site — Rimavská Sobota
  • Seaport Investigator Site — Vranov nad Topľou

Identifiers

NCT: NCT07161700 · SPT-300-2024-204 · 2025-522347-18-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗