Trials / Recruiting
RecruitingNCT07065240
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)
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Seaport Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPT-300 | A prodrug of allopregnanolone, a small molecule drug |
| DRUG | Placebo | Placebo for SPT-300 |
Timeline
- Start date
- 2025-06-19
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2025-07-15
- Last updated
- 2026-03-24
Locations
45 sites across 6 countries: United States, Bulgaria, Czechia, Germany, Poland, Slovakia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07065240. Inclusion in this directory is not an endorsement.