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)
NCT ID: NCT07161700
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
360 participants
INTERVENTIONAL
2025-09-02
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SPT-300
Participants will receive SPT-300 capsules once daily for 42 days
SPT-300
A prodrug of allopregnanolone, a small molecule drug
Interventions
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SPT-300
A prodrug of allopregnanolone, a small molecule drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
66 Years
ALL
No
Sponsors
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Premier Research
OTHER
Seaport Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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David Walling, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Collaborative Neuroscience Research - Garden Grove
Locations
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Seaport Investigator Site
Chino, 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
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
Bialystok, , Poland
Seaport Investigator Site
Bialystok, , Poland
Seaport Investigator Site
Bydgoszcz, , Poland
Seaport Investigator Site
Gdansk, , Poland
Seaport Investigator Site
Poznan, , Poland
Countries
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Other Identifiers
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2025-522347-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
SPT-300-2024-204
Identifier Type: -
Identifier Source: org_study_id
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