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

Condition studied

Major Depressive Disorder (MDD), with or without Anxious Distress

Eligibility

Primary endpoint

Incidence, severity, and duration of treatment-emergent adverse events, serious adverse events, and incidence of clinically significant vital signs, electrocardiograms, safety laboratory, and physical examination findings, Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale

Endpoint detail

Change from Baseline to Visit 6 (Study Day 42) in the following: • HAM-D-17 total score • CGI-S • Hamilton Anxiety Rating Scale • PGI-S • Sheehan Disability Scale • The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form