Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07076407

PHASE3

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

Sponsor: Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

X-NOVA3 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

2025-07-08

Completion Date

2027-07

Last Updated

2026-04-08

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 (42)

Harmonex Neuroscience Research

Dothan, Alabama, United States

University of Alabama at Birmingham, Huntsville Regional Medical Campus

Huntsville, Alabama, United States

Pillar Clinical Research

Bentonville, Arkansas, United States

SanRo Clinical Research Group

Bryant, Arkansas, United States

Clinical Innovations Inc

Bellflower, California, United States

Center for Neurohealth

La Jolla, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Pacific Clinical Research Management Group

Upland, California, United States

Institute of Living

Hartford, Connecticut, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Equipath Health and Research Tampa Bay, Llc

Riverview, Florida, United States

Delricht Research

Atlanta, Georgia, United States

Emory University Brain Health Center

Atlanta, Georgia, United States

Advanced Quality Medical Research

Orland Park, Illinois, United States

Smart Trials, LLC

Jefferson, Louisiana, United States

Pharmasite Research Inc.

Baltimore, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Activmed Practices & Research, Llc - Methuen

Methuen, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

Vitalix Clinical, Inc

Worcester, Massachusetts, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, United States

Lumina Clinical Research Center

Cherry Hill, New Jersey, United States

Princeton Medical Institute

Princeton, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Bioscience Research, LLC

Mount Kisco, New York, United States

Fieve Clinical Research, Inc.

New York, New York, United States

IMA Clinical Research

New York, New York, United States

Magnolia Clinical Research, Llc

Cary, North Carolina, United States

Insight Clinical Trials

Independence, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Austin Clinical Trial Partners

Austin, Texas, United States

Boeson Research

Provo, Utah, United States

Suomen Terveystalo Oy

Helsinki, Finland

Oulu Mentalcare Oy

Oulu, Finland

Clinical Medical Research Sp. z o.o.

Katowice, Poland

Praktyka Lekarska Malgorzata Wojtanowska-Bogacka

Poznan, Poland

Specjalistyczna Praktyka Lekarska, Filip Rybakowski

Poznan, Poland

Clinica Nutrimed Cercetare Sr

Bucharest, Romania

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas

Liptovský Mikuláš, Slovakia