NCT07065240Phase 2Recruiting

A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 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 completion2027-03Estimated

Enrollment · participants360Estimated

Source updated2026-09-14Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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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
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score; description: HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.; timeFrame: Baseline (Day 0) to Day 42

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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