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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
360
A prodrug of allopregnanolone, a small molecule drug
Seaport Investigator Site
Chino, California, United States
Seaport Investigator Site
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
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.
Time frame: Up to Day 49
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Glendale, California, United States
Seaport Investigator Site
West Palm Beach, Florida, United States
Seaport Investigator Site
Atlanta, Georgia, United States
Seaport Investigator Site
Decatur, Georgia, United States
Seaport Investigator Site
Boston, Massachusetts, United States
Seaport Investigator Site
St Louis, Missouri, United States
Seaport Investigator Site
Brooklyn, New York, United States
Seaport Investigator Site
New York, New York, United States
Seaport Investigator Site
Staten Island, New York, United States
...and 12 more locations