A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Description

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)

Conditions

Major Depressive Disorder

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Study Overview

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Study Details

Study overview

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)

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

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, United States, 32256

Orlando

Clinical Neuroscience Solutions, Inc., Orlando, Florida, United States, 32801

Albuquerque

IMA Clinical Research, Albuquerque, New Mexico, United States, 87109

Memphis

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, United States, 38119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 onset; Posttraumatic 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 ≥2 lifetime suicide attempts.
  • * 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.

Ages Eligible for Study

18 Years to 74 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Xenon Pharmaceuticals Inc.,

Study Record Dates

2026-10