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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Sponsor: Xenon Pharmaceuticals Inc.
Summary
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-08-08
Completion Date
2028-08
Last Updated
2026-09-02
Healthy Volunteers
No
Interventions
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Locations (44)
Noble Clinical Research
Tucson, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Clinical Innovations Inc
Bellflower, California, United States
ProScience Research Group
Culver City, California, United States
ATP Clinical Research
Orange, California, United States
NRC Research Institute
Orange, California, United States
Clinical Innovations Inc
Riverside, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
PharmaSouth Research, LLC
Coral Gables, Florida, United States
Sarkis Clinical Research
Gainesville, Florida, United States
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, United States
Central Miami Medical Institute
Miami, Florida, United States
Clinical Neuroscience Solutions, LLC
Orlando, Florida, United States
Synexus Clinical Research, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Denali Health Atlanta, LLC
Stone Mountain, Georgia, United States
Revival Research Institute
Elgin, Illinois, United States
Advanced Quality Medical Research
Orland Park, Illinois, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Redbird Clinical Research, LLC
Las Vegas, Nevada, United States
Lumina Clinical Research Center
Cherry Hill, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Neurobehavioral Research Inc
Cedarhurst, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
DelRicht Research
Charlotte, North Carolina, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions, LLC
Memphis, Tennessee, United States
Elevate Synapsis, LLC
Atascocita, Texas, United States
Memorial Hermann Village
Houston, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States
Multiprofile Hospital for Active Treatment "Dr. Hristo Stambolski"
Kazanlak, Bulgaria
State Psychiatric Hospital Lovech
Lovech, Bulgaria
Saint Naum Medical Center
Sofia, Bulgaria
Diagnostic and Consulting Center XI Sofia
Sofia, Bulgaria
Diagnostics-Consultative Center Mladost M Varna OOD
Varna, Bulgaria
Universitätsklinikum Carl Gustav Carus, TU Dresden - Klinik und Poliklinik für Psychiatrie
Dresden, Germany
University Hospital Münster
Münster, Germany
Instituto de Psiquiatría y Salud Mental. Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
HU. Álvaro Cunqueiro
Pontevedra, Spain