A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)

Xenon Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Bipolar II Disorder; Bipolar I Disorder; Bipolar Disorder; Bipolar Depression

Treatments: Drug: Placebo; Drug: Azetukalner

Study type: Interventional

Funder types: Industry

Identifiers

NCT07172516

XPF-010-B301

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

400 participants in 2 patient groups, including a placebo group

Azetukalner

Experimental group

Description:

Azetukalner 20 mg

Treatment:

Drug: Azetukalner

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo