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 States360 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 range18 Years – 65 Years

SexALL

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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.

What they're measuring

Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score

Timeframe: Baseline (Day 0) to Day 42

Trial details

NCT IDNCT07065240

SponsorSeaport Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Clinical trial information desk

617-807-4062 clinicaltrials@seaporttx.com

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials