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
- Belchatow, Bialystok, Białystok, Bydgoszcz, Gdansk, Leszno, Poznan, Pruszkow, and Tuszyn, PolandSee the 9 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depressive disorder, with or without anxious distress, who finished the earlier BUOY-1 study (SPT-300-2024-203). It is a 6-week extension where everyone gets SPT-300.
- Age
- 18 Years to 66 Years
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder, with or without anxious distress.
- Earlier treatment
- Must have completed treatment in the BUOY-1 study (SPT-300-2024-203), up to Visit 8 (Day 42).
Main reasons for not taking part
- Women who are pregnant (positive urine pregnancy test) or breastfeeding
- Did not follow the study procedures or treatment in the BUOY-1 study
- Use of drugs of abuse
- Anyone the Investigator, medical monitor or Sponsor says should not take part
Read by machine on 11 November 2026.
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 Poland
- Gabinet Lekarski Psychiatryczny Ireneusz KaczorowskiBelchatow, PolandTaking people
- MlynowaMed Specjalistyczny Psychiatryczny Gabinet LekarskiBialystok, PolandTaking people
- Włókiennicza Med Specjalistyczna Praktyka Lekarska Dr n. med. Tomasz MarkowskiBiałystok, PolandTaking people
- Przychodnia Srodmiescie SP. z o.o.Bydgoszcz, PolandTaking people
- E4r&D Sp. z o.o.Gdansk, PolandTaking people
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTISLeszno, PolandTaking people
- Filip Rybakowski Specjalistyczna Praktyka LekarskaPoznan, PolandTaking people
- Mazowieckie Specjalistyczne Centrum Zdrowia im. prof. Jana MazurkiewiczaPruszkow, PolandTaking people
- Inventiva Biomedical And Research Sp. z o.o.Tuszyn, PolandTaking 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.