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

NCT07786454

This study is recruiting at 2 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

Summary

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Generalized Anxiety Disorder

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Last updated on ClinicalTrials.gov
October 20, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Clinical Neuroscience Solutions, LLC · Jacksonville, FL

New York · 1

  • Basil Clinical · Jamaica, NY

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.