A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
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)
Xenon Pharmaceuticals Inc.
400 participants
Aug 8, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT07172516