Phase 3 Trial Comparing Fixed Doses of SEP-363856 to Placebo for Adults With Generalized Anxiety Disorder

What This Trial Is About

Researchers are conducting a global phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of fixed doses of SEP-363856 compared to placebo in adults aged 18 years and older with generalized anxiety disorder GAD. This randomized, double-blind, parallel-group, placebo-controlled study aims to assess how well SEP-363856 works in reducing anxiety symptoms over an 8-week period. Participants are assigned to one of three groups one group receives 50 mg of SEP-363856 daily for 56 days another group starts with 50 mg daily for the first 3 days then increases to 75 mg daily through day 56 the third group receives a placebo tablet daily for 56 days. All treatments are taken orally once a day. This structure allows comparison of two fixed doses of SEP-363856 against placebo during the treatment period. During the study, participants will be regularly assessed for changes in anxiety symptoms using the Hamilton Anxiety Rating Scale and Clinical Global Impression-Severity Score at the beginning and end of the 8 weeks. Researchers will monitor safety, tolerability, and response rates. Participants are expected to attend scheduled visits for evaluations, laboratory tests, and adherence checks throughout the 8-week treatment. The total study duration includes screening and treatment phases, concluding after the final assessments at week 8.

A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder