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).
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.
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.
Parallel
Azetukalner
DrugAzetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
DrugPlacebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6.
Change from baseline in the MADRS total score at Week 1.
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.
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This trial is not recruiting at the moment. You can still explore other options:
