An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in P… (NCT07161700) | Clinical Trial Compass
By InvitationPhase 2
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)
United States, Bulgaria, Czechia360 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range
18 Years – 66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 open-label extension study for SPT-300, what do the safety and tolerability results from the original BUOY-1 trial look like so far, and what does that mean for what I might experience if I participated?
2This trial is enrolling by invitation only, which suggests participants need to have been in the earlier BUOY-1 study — do I qualify to be considered, and if not, are there other SPT-300 or similar trials I could potentially join?
3Because the main thing being measured here is safety and tolerability rather than effectiveness, what would it mean for my actual depression treatment if I enrolled — would I still have access to standard antidepressant options alongside this study drug?
4What kinds of treatment-emergent adverse events or serious adverse events have been flagged in SPT-300 studies so far, and how do those risks compare to the standard treatments I might otherwise try for my MDD with anxious distress?
5Given that this is an extension study with an open-label design, meaning both the doctor and I would know I'm taking SPT-300, how might that affect how we interpret whether the treatment is actually helping my symptoms over time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures