A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bi
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).
| Condition(s) | Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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). |
| Who can participate | 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, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression. * Participant has any nonbipolar psychiatric diagnosis. * Participant has a substance use d |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Lead sponsor | Xenon Pharmaceuticals Inc. |
| Locations | Tucson, Arizona, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Bellflower, California, United States; Culver City, California, United States; Orange, California, United States (+22 more sites) |
| Start date | 2025-08-08 |
| NCT ID | NCT07172516 |
| Official listing | https://clinicaltrials.gov/study/NCT07172516 |