Long-Term Safety and Tolerability Study of SEP-363856 in Adults with Generalized Anxiety Disorder An Open-Label Phase 3 Extension Trial

What This Trial Is About

Researchers are evaluating the long-term safety, tolerability, and effectiveness of SEP-363856 in adults with generalized anxiety disorder GAD. This Phase 3, global, open-label extension trial focuses on adults who have previously participated in related studies and continued treatment without interruption. The main goal is to understand how well participants tolerate SEP-363856 and to monitor any side effects over a 26-week period. Participants will take oral tablets of SEP-363856 at doses of either 50 mg or 75 mg once daily for up to 26 weeks. This study does not include a placebo group, and all participants receive the active drug. Treatment continues throughout the study, with safety and anxiety symptoms assessed at specific intervals. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, or reasons leading to discontinuation. Researchers will also assess changes in anxiety severity using the Hamilton Anxiety Rating Scale and Clinical Global Impression-Severity scores at baseline and weeks 8, 14, and 26. Participants are expected to comply with the visit schedule and study procedures during this period.

A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder