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
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2025-06-19
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPT-300
Participants will receive SPT-300 capsules once daily for 42 days
SPT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Participants will receive matching placebo once daily for 42 days
Placebo
Placebo for SPT-300
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo for SPT-300
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Premier Research
OTHER
Seaport Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Walling, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Collaborative Neuroscience Research - Garden Grove
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seaport Investigator Site
Chino, California, United States
Seaport Investigator Site
Garden Grove, California, United States
Seaport Investigator Site
Glendale, California, United States
Seaport Investigator Site
Cromwell, Connecticut, 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
Marietta, Georgia, United States
Seaport Investigator Site
Boston, Massachusetts, 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
Independence, Ohio, 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
Pilsen, , Czechia
Seaport Investigator Site
Prague, , Czechia
Seaport Investigator Site
Prague, , Czechia
Seaport Investigator Site
Prague, , Czechia
Seaport Investigator Site
Prague, , Czechia
Seaport Investigator Site
Bełchatów, , Poland
Seaport Investigator Site
Bialystok, , Poland
Seaport Investigator Site
Bialystok, , Poland
Seaport Investigator Site
Bydgoszcz, , Poland
Seaport Investigator Site
Gdansk, , Poland
Seaport Investigator Site
Katowice, , Poland
Seaport Investigator Site
Poznan, , Poland
Seaport Investigator Site
Torun, , Poland
Seaport Investigator Site
Tuszyn, , Poland
Seaport Investigator Site
Warsaw, , Poland
Seaport Investigator Site
Wroclaw, , Poland
Seaport Investigator Site
Rimavská Sobota, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-521240-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
SPT-300-2024-203
Identifier Type: -
Identifier Source: org_study_id