RecruitingPhase 3NCT06775379

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder


Sponsor

Xenon Pharmaceuticals Inc.

Enrollment

450 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called azetukalner as a treatment for major depressive disorder (MDD) — a serious form of depression that significantly affects daily life. Researchers want to find out if this drug works better than a placebo (inactive pill) in reducing depression symptoms. **You may be eligible if...** - You are between 18 and 74 years old - You have been diagnosed with major depressive disorder and are currently in a depressive episode - Your current episode of depression has lasted between 6 weeks and 24 months - Your first depressive episode started before age 50 - Your BMI is 40 or below **You may NOT be eligible if...** - Your primary diagnosis is something other than MDD (e.g., bipolar disorder, schizophrenia, or OCD) - You have a history of psychotic depression, mixed features depression, or catatonia - You have bipolar I or II disorder 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(46)

IMA Clinical Research Phoenix

Phoenix, Arizona, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Behavioral Research Specialists, Llc

Glendale, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Irvine Clinical Research

Irvine, California, United States

CalNeuro Research Group, Inc.

Los Angeles, California, United States

Excell Research Inc.

Oceanside, California, United States

Atp Clinical Research

Orange, California, United States

Nrc Research Institute

Orange, California, United States

CenExel CNS-TO (Collaborative Neuroscience Research)

Torrance, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Ct Clinical Research Associates

Cromwell, Connecticut, United States

CNS Clinical Research Group

Coral Springs, Florida, United States

NeoClinical Research

Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Accel Research Sites Lakeland

Lakeland, Florida, United States

Accel Research Sites - St. Petersburg-Largo

Largo, Florida, United States

PharmaSouth Research

Miami, Florida, United States

Quantum Clinical Trials

Miami Beach, Florida, United States

Harmony Clinical Research Inc

North Miami Beach, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Combined Research Orlando Phase I-Iv

Orlando, Florida, United States

Panhandle Research and Medical Clinic

Pensacola, Florida, United States

Advanced Discovery Research

Atlanta, Georgia, United States

Synexus - Atlanta

Atlanta, Georgia, United States

CenExel iResearch

Decatur, Georgia, United States

Psych Atlanta, Pc

Marietta, Georgia, United States

Cenexel Iresearch - Savannah

Savannah, Georgia, United States

Northwest Clinical Trials Inc

Boise, Idaho, United States

Chicago Research Center Inc.

Chicago, Illinois, United States

Boston Clinical Trials Llc

Boston, Massachusetts, United States

ELIXIA

Springfield, Massachusetts, United States

IMA Clinical Research Las Vegas

Las Vegas, Nevada, United States

Redbird Research

Las Vegas, Nevada, United States

IMA Clinical Research

Albuquerque, New Mexico, United States

Integrative Clinical Trials

Brooklyn, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Pahl Pharmaceutical Professionals Llc

Oklahoma City, Oklahoma, United States

Lehigh Center For Clinical Research

Allentown, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Delricht Research - Plano

Plano, Texas, United States

Aim Trials, Llc

Plano, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Core Clinical Research

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06775379


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