ENROLLING_BY_INVITATION

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)

Talk to us

Conditions

Major Depressive Disorder (MDD)Major Depressive Disorder With Anxious DistressMajor Depressive DisorderDepressive DisorderDepressionAnxietyMood DisordersSPT-300LYT-300GlyphAlloGlyph AllopregnanoloneBUOY-1 OLE StudyAnxious DistressOpen Label Extension Study

Quick Navigation

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 an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Official Title

A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress

Quick Facts

Study Start:2025-09-02
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT07161700

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 66 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]).
  2. * 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.
  3. * Participant is willing and able to refrain from the use of drugs of abuse.
  1. * Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.
  2. * 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).
  3. * 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.

Contacts and Locations

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
Garden Grove, California, 92845-2506
United States
Seaport Investigator Site
Glendale, California, 91206
United States
Seaport Investigator Site
Cromwell, Connecticut, 06416
United States
Seaport Investigator Site
West Palm Beach, Florida, 33407
United States
Seaport Investigator Site
Atlanta, Georgia, 30328
United States
Seaport Investigator Site
Decatur, Georgia, 30030
United States
Seaport Investigator Site
Marietta, Georgia, 30060
United States
Seaport Investigator Site
Boston, Massachusetts, 02116
United States
Seaport Investigator Site
Boston, Massachusetts, 02131
United States
Seaport Investigator Site
St Louis, Missouri, 63141
United States
Seaport Investigator Site
Brooklyn, New York, 11235
United States
Seaport Investigator Site
New York, New York, 10029
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 Date2025-09-02
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-09-02
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • Depressive Disorder
  • Depression
  • Anxiety
  • Mood Disorders
  • SPT-300
  • LYT-300
  • GlyphAllo
  • Glyph Allopregnanolone
  • BUOY-1 OLE Study
  • Anxious Distress
  • Open Label Extension Study

Additional Relevant MeSH Terms

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