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

RecruitingPhase 3

Sponsor: Xenon Pharmaceuticals Inc.

Conditions: Major Depressive Disorder

Interventions: Azetukalner, Placebo

Countries: United States, Finland, Germany, Poland, Romania, Slovakia, Spain

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)

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (48)

Dothan, Alabama, United States
Huntsville, Alabama, United States
Bentonville, Arkansas, United States
Bryant, Arkansas, United States
Bellflower, California, United States
La Jolla, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Upland, California, United States
Hartford, Connecticut, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Riverview, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Orland Park, Illinois, United States
Jefferson, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Methuen, Massachusetts, United States
Watertown, Massachusetts, United States
Worcester, Massachusetts, United States
O'Fallon, Missouri, United States
Saint Charles, Missouri, United States
Cherry Hill, New Jersey, United States
Princeton, New Jersey, United States
Toms River, New Jersey, United States
Mount Kisco, New York, United States
New York, New York, United States
New York, New York, United States
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