A Phase 2 Study to Test the Safety and Effectiveness of SPT-300 Capsules for Adults With Major Depressive Disorder, With or Without Anxiety

What this Trial Is About

Researchers are evaluating the effectiveness and safety of SPT-300 GlyphAllo, a drug being studied for adults with major depressive disorder MDD, including those with or without anxious distress. This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess how well SPT-300 works and how well participants tolerate it. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. The study compares these two groups to understand the impact of SPT-300 as a monotherapy treatment for MDD. During the study, participants will be assessed for changes in depression severity using the Hamilton Depression Rating Scale-17 HAM-D-17 from the start to day 42 of treatment. Additional evaluations include clinical global impression severity scores. The trial includes monitoring for safety, tolerability, and other health measures throughout the 42-day treatment period.

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)