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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)

NCT ID: NCT07065240
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 2
Sponsor: Seaport Therapeutics

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 360 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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. Exclusion Criteria: * History of, or current presentation consistent with: 1. any depressive episode with psychotic or catatonic features. 2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode. 3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression. 4. schizophrenia, schizoaffective, or other psychotic disorder. 5. obsessive-compulsive disorder. 6. 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. * Participant has a history of drug or alcohol use disorder. * Participants with a positive test for cannabinoids. * Clinically significant risk of suicide or harm to self or others.

Study locations

53 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Bulgaria, Czechia, Germany, Hungary, Poland, Slovakia, United States

Brandenburg, Germany: 1
Mecklenburg-Vorpommern, Germany: 1
California, United States: 5
Connecticut, United States: 1
Florida, United States: 5
Georgia, United States: 3
Massachusetts, United States: 2
Missouri, United States: 1
New York, United States: 4
Ohio, United States: 2
Pennsylvania, United States: 1
Texas, United States: 3
Washington, United States: 1

Sample of listed locations

Seaport Investigator Site — Lovech, 5500, Bulgaria — Site recruitment status not specified in the registry data
Seaport Investigator Site — Plovdiv, 4004, Bulgaria — Site recruitment status not specified in the registry data
Seaport Investigator Site — Sofia, 1000, Bulgaria — Site recruitment status not specified in the registry data
Seaport Investigator Site — Brno, 602 00, Czechia — Site recruitment status not specified in the registry data
Seaport Investigator Site — Pilsen, 301 00, Czechia — Site recruitment status not specified in the registry data
Seaport Investigator Site — Prague, 100 00, Czechia — Site recruitment status not specified in the registry data
Seaport Investigator Site — Berlin, Brandenburg, D-10629, Germany — Site recruitment status not specified in the registry data
Seaport Investigator Site — Schwerin, Mecklenburg-Vorpommern, 19053, Germany — Site recruitment status not specified in the registry data
Seaport Investigator Site — Bad Homburg, 61348, Germany — Site recruitment status not specified in the registry data
Seaport Investigator Site — Chemnitz, 09111, Germany — Site recruitment status not specified in the registry data
Seaport Investigator Site — Budapest, 1033, Hungary — Site recruitment status not specified in the registry data
Seaport Investigator Site — Bełchatów, 97-400, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Bialystok, 15-404, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Bydgoszcz, 85-080, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Gdansk, 80-438, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Katowice, 40-600, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Leszno, 64-100, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Poznan, 60-744, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Torun, 87-100, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Tuszyn, 95-080, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Warsaw, 00-124, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Wroclaw, 54-617, Poland — Site recruitment status not specified in the registry data
Seaport Investigator Site — Bratislava, 82007, Slovakia — Site recruitment status not specified in the registry data
Seaport Investigator Site — Rimavská Sobota, 979 01, Slovakia — Site recruitment status not specified in the registry data
Seaport Investigator Site — Vranov nad Topľou, 09301, Slovakia — Site recruitment status not specified in the registry data

Study details

Start date: June 19, 2025
Primary completion date: March 1, 2027
First posted: July 15, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07065240
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07065240 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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