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)
Purpose
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.
Conditions
- Major Depressive Disorder (MDD)
- Major Depressive Disorder With Anxious Distress
Eligibility
- Eligible Ages
- Between 18 Years and 66 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SPT-300 |
Participants will receive SPT-300 capsules once daily for 42 days |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Seaport Therapeutics
