Study of Solriamfetol Treatment for Adults 18 to 65 With Major Depressive Disorder and Excessive Daytime Sleepiness

What this Trial Is About

Researchers are studying the effects of solriamfetol in adults aged 18 to 65 years who have major depressive disorder MDD accompanied by excessive daytime sleepiness EDS. This Phase 3 trial is designed to evaluate the treatments ability to maintain clinical response and prevent relapse of depressive symptoms during a randomized withdrawal period. The study includes multiple centers and uses a double-blind, placebo-controlled, randomized withdrawal design to provide reliable results. Participants first enter a screening phase, followed by an open-label treatment period where all receive solriamfetol tablets once daily. Those who respond clinically are then randomized to either continue solriamfetol or switch to placebo in a double-blind manner. This randomized withdrawal period continues until relapse of depressive symptoms or up to 24 weeks. The study concludes with a follow-up period to monitor outcomes. Throughout the trial, participants will be closely monitored using clinical assessments to evaluate the time to relapse of depressive symptoms. Study staff will assess adherence and response during the open-label and randomized phases. The total participation duration varies depending on individual response and relapse, with the primary outcome measured up to 24 weeks after randomization. The trial aims to provide detailed information on the treatments role in managing depression with excessive sleepiness.

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol