Clinical Trial

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Study acronym: X-CEED
Recruiting Phase 3
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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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-09-08; most recent amendment 2026-06-01.
Trial Details
NCT Number NCT07172516
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
Enrollment 400 participants
Start Date 2025-08-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-03