Bipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
Conditions
Keywords
Bipolar, XEN1101, Azetukalner
Brief 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).
Interventions
DRUGAzetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
DRUGPlacebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Sponsors
Xenon Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion 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, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. | Baseline to Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6. | Baseline to Week 6 |
| Change from baseline in the MADRS total score at Week 1. | Baseline to Week 1 |
| Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6. | Baseline to Week 6 |
Countries
Bulgaria, Germany, Spain, United States
Contacts
CONTACTXenon Medical Affairs
Outcome results
None listed