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.
You may not be if
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.
Clareo Health | A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
