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

This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

NCT Number	NCT07759128
Lead Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions	Generalized Anxiety Disorder
Enrollment	576 participants
Start Date	2026-07-28
Primary Completion	2028-12-06 (estimated)
Study Completion	2028-12-13 (estimated)
Updated on ClinicalTrials.gov	2026-08-12