A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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 disorder (excluding tobacco) within the 6 months prior to screening visit. - Participant has a symptomatic eating disorder within the 12 months prior to screening visit. - Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization. - Participant has been hospitalized for mania within the 30 days prior to screening visit. - Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks). - Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or ≥2 lifetime suicide attempts. - Participant has self-injurious behavior without intent to die in the 12 months prior to screening. - Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 2 weeks or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization. - Participants with medical conditions that may interfere with the purpose or conduct of the study. - Participant is pregnant, breastfeeding, or planning to become pregnant.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Azetukalner |
Azetukalner 20 mg |
|
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Xenon Pharmaceuticals Inc.
