A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
In brief
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).
Key facts
- Study ID
- NCT07172516
- Run by
- Xenon Pharmaceuticals Inc.
- People needed
- 400
- Starts
- 2025-08-08
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Noble Clinical Research — Tucson, Arizona, United States (enrolling)
- Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
- Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
- Clinical Innovations Inc — Bellflower, California, United States (enrolling)
- ProScience Research Group — Culver City, California, United States (enrolling)
- ATP Clinical Research — Orange, California, United States (enrolling)
- NRC Research Institute — Orange, California, United States (enrolling)
- Clinical Innovations Inc — Riverside, California, United States (enrolling)
- PharmaSouth Research, LLC — Coral Gables, Florida, United States (enrolling)
- Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States (enrolling)
- Central Miami Medical Institute — Miami, Florida, United States (enrolling)
- Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States (enrolling)
- Synexus Clinical Research, Inc. — Atlanta, Georgia, United States (enrolling)
- Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
- CenExel iResearch — Decatur, Georgia, United States (enrolling)
- Denali Health Atlanta, LLC — Stone Mountain, Georgia, United States (enrolling)
- Advanced Quality Medical Research — Orland Park, Illinois, United States (enrolling)
- Psychiatric Care and Research Center — O'Fallon, Missouri, United States (enrolling)
- Redbird Clinical Research, LLC — Las Vegas, Nevada, United States (enrolling)
- Lumina Clinical Research Center — Cherry Hill, New Jersey, United States (enrolling)
- Integrative Clinical Trials LLC — Brooklyn, New York, United States (enrolling)
- Neurobehavioral Research Inc — Cedarhurst, New York, United States (enrolling)
- DelRicht Research — Charlotte, North Carolina, United States (enrolling)
- Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States (enrolling)
- Clinical Neuroscience Solutions, Inc — Memphis, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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