Status:
ENROLLING_BY_INVITATION
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)
Lead Sponsor:
Seaport Therapeutics
Collaborating Sponsors:
Premier Research
Conditions:
Major Depressive Disorder (MDD)
Major Depressive Disorder With Anxious Distress
Eligibility:
All Genders
18-66 years
Phase:
PHASE2
Brief Summary
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.
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.
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07161700
Start Date
September 2 2025
End Date
May 1 2027
Last Update
December 15 2025
Active Locations (15)
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1
Seaport Investigator Site
Chino, California, United States, 91710
2
Seaport Investigator Site
Glendale, California, United States, 91206
3
Seaport Investigator Site
Atlanta, Georgia, United States, 30328
4
Seaport Investigator Site
Decatur, Georgia, United States, 30030