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

Not Applicable

Recruiting

• Conditions: Bipolar Disorder; Bipolar I Disorder; Bipolar Depression; Bipolar II Disorder
• Interventions: Drug: Azetukalner; Drug: Placebo

• Registration Number: NCT07172516
• Lead Sponsor: Xenon Pharmaceuticals Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-08
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Study First Posted: 2025-09-15
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-06
• Last Update Posted: 2025-10-09
• Primary Completion: 2028-06
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azetukalner	Azetukalner	Azetukalner 20 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.	Baseline to Week 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

ATP Clinical Research; 🇺🇸 Orange, California, United States

PharmaSouth Research, LLC; 🇺🇸 Coral Gables, Florida, United States

Center For Emotional Fitness; 🇺🇸 Cherry Hill, New Jersey, United States

Grayline Research Center; 🇺🇸 Wichita Falls, Texas, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Woodland Research Northwest; 🇺🇸 Rogers, Arkansas, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Jacksonville, Florida, United States

Clinical Neuroscience Solutions, Inc; 🇺🇸 Memphis, Tennessee, United States