A Randomized, Double-Blind, Placebo-Controlled Study of SPT-300 for Adults With Major Depressive Disorder, With or Without Anxious Distress

What this Trial Is About

Researchers are studying the effects of SPT-300 GlyphAllo, a prodrug of allopregnanolone, in adults with major depressive disorder MDD, including those with or without anxious distress. This randomized, double-blind, placebo-controlled study aims to evaluate the drugs efficacy, safety, and tolerability in this population. The study is a Phase 2 trial designed to provide important information about SPT-300 as a monotherapy treatment for MDD. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. This parallel-group design ensures that both groups are treated similarly except for the active drug, allowing researchers to compare the effects accurately. The study focuses solely on monotherapy, meaning no additional antidepressant treatments are given during this period. During the trial, participants will be assessed at the start and after 42 days of treatment using the Hamilton Depression Rating Scale-17 HAM-D-17 to measure changes in depression severity. Safety and tolerability will also be monitored throughout the study. Additional evaluations include the Clinical Global Impression - Severity CGI-S scale to assess overall illness severity. The total participation time corresponds to the 42-day treatment period, with monitoring to ensure adherence and safety.

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)