A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Dep… (NCT07065240) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
United States, Bulgaria, Czechia360 participantsStarted 2025-06-19
Plain-language summary
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, 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 – 65 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.
Exclusion criteria
. any depressive episode with psychotic or catatonic features.
. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
. schizophrenia, schizoaffective, or other psychotic disorder.
. obsessive-compulsive disorder.
. any persistent neurocognitive disorder.
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.
1SPT-300 (GlyphAllo) is being tested in a Phase 2 trial, which means its safety and effectiveness are still being established — given that, what do we currently know about its safety profile, and how does that uncertainty compare to antidepressants I could start right now?
2This trial measures depression symptoms using the HAM-D-17 scale at 42 days — does a 6-week timeframe actually give us enough information about whether a treatment is working for my type of depression, especially if I also have anxious distress?
3The trial includes people both with and without anxious distress — based on my specific symptoms, do you think I'd be more likely to benefit from a study like this, or would a more targeted existing treatment be a better first step?
4Since this is still a recruiting Phase 2 study, there's no published efficacy data yet — would it make sense for me to try a standard antidepressant first and consider a trial like this if that doesn't work, or is there a reason to think about it now?
5What would participation in this trial actually look like for my day-to-day life over those 42 days — how many visits, what kind of monitoring, and what happens if my depression worsens during the study?
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
Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score