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

RECRUITINGPHASE3

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

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516•Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

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.

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.
+2 more criteria

Locations (26)

Noble Clinical Research

Tucson, Arizona, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Clinical Innovations Inc

Bellflower, California, United States

ProScience Research Group

Culver City, California, United States

ATP Clinical Research

Orange, California, United States

NRC Research Institute

Orange, California, United States

Clinical Innovations Inc

Riverside, California, United States

PharmaSouth Research, LLC

Coral Gables, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Key Dates

Start Date

August 8, 2025

Primary Completion Date

June 1, 2028

Completion Date

August 1, 2028

Last Updated

February 3, 2026

Enrollment

400

ESTIMATED participants

Conditions

Bipolar DisorderBipolar DepressionBipolar I DisorderBipolar II Disorder

Interventions

Azetukalner

DRUG

Placebo

DRUG

Contacts

Xenon Medical Affairs

CONTACT

1-604-484-3300 XenonCares@xenon-pharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

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