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)

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Conditions

Major Depressive Disorder (MDD)Major Depressive Disorder With Anxious DistressMajor Depressive DisorderDepressive DisorderDepressionAnxietyMood DisordersBUOY-1 StudySPT-300LYT-300GlyphAlloGlyph Allopregnanolone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress

Quick Facts

Study Start:2025-07-14
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07065240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
  4. * 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.
  5. * Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
  6. * Participant is willing and able to refrain from the use of drugs of abuse.
  1. * History of, or current presentation consistent with:
  2. 1. any depressive episode with psychotic or catatonic features.
  3. 2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
  4. 3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
  5. 4. schizophrenia, schizoaffective, or other psychotic disorder.
  6. 5. obsessive-compulsive disorder.
  7. 6. any persistent neurocognitive disorder.
  8. * History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
  9. * Psychiatric hospitalization within current depressive episode.
  10. * Evidence or history of clinically significant diseases which can affect the patients' participation.
  11. * Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
  12. * Participant has a history of drug or alcohol use disorder.
  13. * Participants with a positive test for cannabinoids.
  14. * Clinically significant risk of suicide or harm to self or others.

Contacts and Locations

Study Contact

Clinical trial information desk
CONTACT
617-807-4062
clinicaltrials@seaporttx.com

Principal Investigator

David Walling, Ph.D.
PRINCIPAL_INVESTIGATOR
Collaborative Neuroscience Research - Garden Grove

Study Locations (Sites)

Seaport Investigator Site
Chino, California, 91710
United States
Seaport Investigator Site
West Palm Beach, Florida, 33407
United States
Seaport Investigator Site
Atlanta, Georgia, 30328
United States
Seaport Investigator Site
Saint Louis, Missouri, 63141
United States
Seaport Investigator Site
Brooklyn, New York, 11235
United States
Seaport Investigator Site
Staten Island, New York, 10314
United States
Seaport Investigator Site
North Canton, Ohio, 44720
United States
Seaport Investigator Site
Irving, Texas, 75062
United States

Collaborators and Investigators

Sponsor: Seaport Therapeutics

  • David Walling, Ph.D., PRINCIPAL_INVESTIGATOR, Collaborative Neuroscience Research - Garden Grove

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • Depressive Disorder
  • Depression
  • Anxiety
  • Mood Disorders
  • BUOY-1 Study
  • SPT-300
  • LYT-300
  • GlyphAllo
  • Glyph Allopregnanolone

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)
  • Major Depressive Disorder With Anxious Distress