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 · Phase 2

Conditions studied: Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress

In brief

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.

Key facts

Study ID

NCT07161700

Run by

Seaport Therapeutics

People needed

360

Starts

2025-09-02

Expected to finish

2027-05-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Seaport Investigator Site — Chino, California, United States
• Seaport Investigator Site — Garden Grove, California, United States
• Seaport Investigator Site — Glendale, California, United States
• Seaport Investigator Site — West Palm Beach, Florida, United States
• Seaport Investigator Site — Atlanta, Georgia, United States
• Seaport Investigator Site — Decatur, Georgia, United States
• Seaport Investigator Site — Boston, Massachusetts, United States
• Seaport Investigator Site — St Louis, Missouri, United States
• Seaport Investigator Site — Brooklyn, New York, United States
• Seaport Investigator Site — New York, New York, United States
• Seaport Investigator Site — Staten Island, New York, United States
• Seaport Investigator Site — Independence, Ohio, United States
• Seaport Investigator Site — North Canton, Ohio, United States
• Seaport Investigator Site — Irving, Texas, United States
• Seaport Investigator Site — Plovdiv, Bulgaria
• Seaport Investigator Site — Sofia, Bulgaria
• Seaport Investigator Site — Brno, Czechia
• Seaport Investigator Site — Prague, Czechia
• Seaport Investigator Site — Prague, Czechia
• Seaport Investigator Site — Prague, Czechia
• Seaport Investigator Site — Prague, Czechia
• Seaport Investigator Site — Schwerin, Mecklenburg-Vorpommern, Germany
• Seaport Investigator Site — Chemnitz, Germany
• Seaport Investigator Site — Bialystok, Poland
• Seaport Investigator Site — Bialystok, Poland

Full record on ClinicalTrials.gov

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