By invitationNCT07161700ClinicalTrials.gov record

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)

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

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 2
Age range: 18 years - 66 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 360 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

SPT-300

Participants will receive SPT-300 capsules once daily for 42 days

Drug: SPT-300

SPT-300 DRUG

A prodrug of allopregnanolone, a small molecule drug

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures

Time frame: 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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (46)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

46 locations

Seaport Investigator SiteChino, California, United StatesStatus unknown