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A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06775379•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)

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

December 20, 2024

Primary Completion Date

August 1, 2026

Completion Date

October 1, 2026

Last Updated

October 22, 2025

Enrollment

450

ESTIMATED participants

Conditions

Major Depressive 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: October 22, 2025Data 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 Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

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