RecruitingPhase 3NCT07172516

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)


Sponsor

Xenon Pharmaceuticals Inc.

Enrollment

400 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called azetukalner (a new type of mood-stabilizing medication) in adults with bipolar I or II disorder who are currently experiencing a depressive episode. It aims to see if azetukalner is more effective than a placebo (inactive pill) at relieving bipolar depression. **You may be eligible if...** - You are between 18 and 74 years old and have bipolar I or II disorder - You are currently in a depressive episode that has lasted at least 4 weeks but no more than 12 months - Your first major depressive episode occurred before age 50 - Your BMI is between 18 and 40 **You may NOT be eligible if...** - You have major depressive disorder (without bipolar disorder) - You have another psychiatric diagnosis beyond bipolar disorder - You have a substance use disorder (other than tobacco) in the past 6 months - You have an eating disorder - You are currently in or recently had a manic episode - You are considered at high risk for suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzetukalner

Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks

DRUGPlacebo

Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks


Locations(27)

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

Central Miami Medical Institute

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Synexus Clinical Research, Inc.

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch

Decatur, Georgia, United States

Denali Health Atlanta, LLC

Stone Mountain, Georgia, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

Redbird Clinical Research, LLC

Las Vegas, Nevada, United States

Lumina Clinical Research Center

Cherry Hill, New Jersey, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Neurobehavioral Research Inc

Cedarhurst, New York, United States

DelRicht Research

Charlotte, North Carolina, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, United States

Elevate Synapsis, LLC

Atascocita, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Eastside Therapeutics Resources, INC dba Core Clinical Research

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07172516


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