A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
NCT07759128
This study is recruiting at 17 US sites in 12 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
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 26, 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
Arizona · 1
- Del Sol Research Management · Tucson, AZ
California · 2
- Pharmacology Research Institute · Encino, CA
- California Neuroscience Research Medical Group, Inc · Sherman Oaks, CA
District of Columbia · 1
- Emerson Clinical Research Institute - Washington, DC · Washington D.C., DC
Florida · 3
- Sarkis Clinical Trials - Gainesville · Gainesville, FL
- Clinical Neuroscience Solutions, LLC · Jacksonville, FL
- Accel Research Sites - Maitland · Maitland, FL
Illinois · 1
- AMR Conventions Research, Inc · Warrenville, IL
Louisiana · 1
- Research Works, Inc · New Orleans, LA
Massachusetts · 1
- Adams Clinical Boston · Boston, MA
Nevada · 1
- Vector Clinical Trials - Las Vegas · Las Vegas, NV
New York · 2
- Adams Clinical Harlem · New York, NY
- Manhattan Behavioral Medicine PLLC · New York, NY
Ohio · 1
- Insight Clinical Trials · Independence, OH
Oklahoma · 1
- Sooner Clinical Research, Inc. · Oklahoma City, OK
Texas · 2
- FutureSearch Trials of Dallas · Dallas, TX
- Adams Clinical Dallas · DeSoto, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.