Back to search results
NCT07161700

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)

Enrolling by Invitation
PHASE2Ages 18–66InterventionalTreatment
Seaport Therapeutics
~360 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:SPT-300

At a glance

Recruiting sites
0 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
Measured over Up to Day 49

Conditions

Major Depressive Disorder (MDD)
Major Depressive Disorder With Anxious Distress

Explore related trials

Unipolar Depression

Where it's being run

32 sites across 14 states
Poland7
Czechia5
California3
New York3
Georgia2
Ohio2
Bulgaria2
Slovakia2

Study leadership

  • David Walling, Ph.D. · PRINCIPAL_INVESTIGATOR · Collaborative Neuroscience Research - Garden Grove

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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.

What this trial measures

  • Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and proceduresUp to Day 49

    Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.