Anxiety & Depression Association of America

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)

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Between 18 Years and 66 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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]). - 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. - Participant is willing and able to refrain from the use of drugs of abuse.

Exclusion Criteria

Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study. - 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). - 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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental SPT-300	Participants will receive SPT-300 capsules once daily for 42 days	Drug: SPT-300 A prodrug of allopregnanolone, a small molecule drug Other names: LYT-300 GlyphAllo Glyph Allopregnanolone

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Seaport Therapeutics

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.