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.

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

Age range: 18–74 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age. * Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2. * Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI). * Current MDE must has a duration of ≥4 weeks and ≤12 months. Key Exclusion Criteria: * Participant has any type of major depressive disorder (MDD) diagnosis,…

Interventions

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

Locations (28)

Noble Clinical Research
Tucson, Arizona
Woodland International Research Group
Little Rock, Arkansas
Woodland Research Northwest
Rogers, Arkansas
Clinical Innovations Inc
Bellflower, California
ProScience Research Group
Culver City, California
ATP Clinical Research
Orange, California