Actively Recruiting
A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
Led by Seaport Therapeutics · Updated on 2026-03-24
360
Participants Needed
45
Research Sites
88 weeks
Total Duration
On this page
Sponsors
S
Seaport Therapeutics
Lead Sponsor
P
Premier Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
- Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
- Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
- Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
- Participant is willing and able to refrain from the use of drugs of abuse.
You will not qualify if you...
- Any depressive episode with psychotic or catatonic features.
- Any bipolar manic, hypomanic or mixed episode, and substance-induced manic, hypomanic/mixed episode.
- Bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
- Schizophrenia, schizoaffective, or other psychotic disorder.
- Obsessive-compulsive disorder.
- Any persistent neurocognitive disorder.
- History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
- Psychiatric hospitalization within current depressive episode.
- Evidence or history of clinically significant diseases which can affect the patients' participation.
- Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
- History of drug or alcohol use disorder.
- Positive test for cannabinoids.
- Clinically significant risk of suicide or harm to self or others.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
Seaport Investigator Site
Chino, California, United States, 91710
Actively Recruiting
2
Seaport Investigator Site
Garden Grove, California, United States, 92845-2506
Actively Recruiting
3
Seaport Investigator Site
Glendale, California, United States, 91206
Actively Recruiting
4
Seaport Investigator Site
Cromwell, Connecticut, United States, 06416
Actively Recruiting
5
Seaport Investigator Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
6
Seaport Investigator Site
Atlanta, Georgia, United States, 30328
Actively Recruiting
7
Seaport Investigator Site
Decatur, Georgia, United States, 30030
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8
Seaport Investigator Site
Marietta, Georgia, United States, 30060
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9
Seaport Investigator Site
Boston, Massachusetts, United States, 02116
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10
Seaport Investigator Site
Boston, Massachusetts, United States, 02131
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11
Seaport Investigator Site
St Louis, Missouri, United States, 63141
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12
Seaport Investigator Site
Brooklyn, New York, United States, 11235
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13
Seaport Investigator Site
New York, New York, United States, 10029
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14
Seaport Investigator Site
Staten Island, New York, United States, 10314
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15
Seaport Investigator Site
Independence, Ohio, United States, 44131
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16
Seaport Investigator Site
North Canton, Ohio, United States, 44720
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17
Seaport Investigator Site
Irving, Texas, United States, 75062
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18
Seaport Investigator Site
Plovdiv, Bulgaria, 4004
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19
Seaport Investigator Site
Sofia, Bulgaria, 1000
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20
Seaport Investigator Site
Sofia, Bulgaria, 1680
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21
Seaport Investigator Site
Brno, Czechia, 602 00
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22
Seaport Investigator Site
Pilsen, Czechia, 301 00
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23
Seaport Investigator Site
Prague, Czechia, 100 00
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24
Seaport Investigator Site
Prague, Czechia, 110 00
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25
Seaport Investigator Site
Prague, Czechia, 160 00
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26
Seaport Investigator Site
Prague, Czechia, 186 00
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27
Seaport Investigator Site
Berlin, Brandenburg, Germany, D-10629
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28
Seaport Investigator Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
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29
Seaport Investigator Site
Bad Homburg, Germany, 61348
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30
Seaport Investigator Site
Chemnitz, Germany, 09111
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31
Seaport Investigator Site
Bełchatów, Poland, 97-400
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32
Seaport Investigator Site
Bialystok, Poland, 15-404
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33
Seaport Investigator Site
Bialystok, Poland, 15-464
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34
Seaport Investigator Site
Bydgoszcz, Poland, 85-080
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35
Seaport Investigator Site
Gdansk, Poland, 80-438
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36
Seaport Investigator Site
Katowice, Poland, 40-600
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37
Seaport Investigator Site
Leszno, Poland, 64-100
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38
Seaport Investigator Site
Poznan, Poland, 60-744
Actively Recruiting
39
Seaport Investigator Site
Torun, Poland, 87-100
Withdrawn
40
Seaport Investigator Site
Tuszyn, Poland, 95-080
Actively Recruiting
41
Seaport Investigator Site
Warsaw, Poland, 00-124
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42
Seaport Investigator Site
Wroclaw, Poland, 54-617
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43
Seaport Investigator Site
Bratislava, Slovakia, 82007
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44
Seaport Investigator Site
Rimavská Sobota, Slovakia, 979 01
Actively Recruiting
45
Seaport Investigator Site
Vranov nad Topľou, Slovakia, 09301
Actively Recruiting
Research Team
C
Clinical trial information desk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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