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)

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

Status

Enrolling by invitation

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07161700

Enrollment

360

Registered

2025-09-09

Start date

2025-09-02

Completion date

2027-05-01

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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.

Interventions

DRUGSPT-300

A prodrug of allopregnanolone, a small molecule drug

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures	Up to Day 49	Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.

Countries

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

Contacts

PRINCIPAL_INVESTIGATORDavid Walling, Ph.D.

Collaborative Neuroscience Research - Garden Grove

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026