Extension study of SPT-300 for adults with major depressive disorder
Tests SPT-300 for safety in adults with major depression, with or without anxiety.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bad Homburg, Berlin, Chemnitz, and Schwerin, GermanySee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 66 years old?
Source: NCT07161700, who can take part
Where in Germany
- Zentrum fuer klinische Forschung Dr. I. Schoell GmbHBad Homburg, GermanyTaking people
- FutureMeds GmbHBerlin, GermanyTaking people
- Pharmakologisches Studienzentrum Chemnitz GmbHChemnitz, GermanyTaking people
- Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbHSchwerin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seaport Therapeutics
- Trial code
- NCT07161700EU 2025-522347-18-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress
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.
Inclusion: 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: 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.