drugset / Trial / NCT07767903

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

NCT07767903 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Timeline

Start
2026-08-06
Primary completion
2028-10-25
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 75 mg Oral