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RECRUITING

NCT06775379

PHASE3

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Sponsor: Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-12-20

Completion Date

2026-10

Last Updated

2025-10-22

Healthy Volunteers

Conditions

Major Depressive Disorder

Interventions

DRUG

Azetukalner

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

DRUG

Placebo

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

Key Inclusion Criteria: * Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age * Body Mass Index (BMI) ≤40 kg/m2 * Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI) * Participant's current MDE has a duration of ≥6 weeks and ≤24 months. Key Exclusion Criteria: * Participant has a primary diagnosis of a mood disorder other than MDD. * Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder. * Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator. * Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening. * Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1 suicide attempt \>24 years of age. * Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening. * Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization. * Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ). * Participants with medical conditions that may interfere with the purpose or conduct of the study * Participant is pregnant, breastfeeding, or planning to become pregnant.

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

Clinical Research Directory

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (46)