A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Sponsored by Xenon Pharmaceuticals Inc.
About this study
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).
Where this study is enrolling (2)
- I'm interested
Noble Clinical Research
Tucson, Arizona
- I'm interested
Memorial Hermann Village
Houston, Texas
Who can participate
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 12 months.
- ✕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 1 week 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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.