NCT07172516

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bipolar Disorder
• Bipolar Depression
• Bipolar I Disorder
• Bipolar II Disorder

Interventions

Type	Name	Description
DRUG	Azetukalner	Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
DRUG	Placebo	Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Timeline

• Start date: 2025-08-08
• Primary completion: 2028-06-01
• Completion: 2028-08-01
• First posted: 2025-09-15
• Last updated: 2026-04-01

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study