NCT07161700Phase 2Enrolling 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)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-05Estimated

Enrollment · participants360Estimated

Source updated2026-08-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-09-30 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Enrolling by invitation

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Study details

Conditions studied

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

Treatments or interventions studied

SPT-300DrugAlso known as LYT-300, GlyphAllo, Glyph Allopregnanolone

Primary outcomes · main study measures

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measure: Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures; description: 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.; timeFrame: Up to Day 49

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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