A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

What this study is about

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)

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• 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

+ 34 more sites.

Who to contact

Xenon Medical Affairs · 1-604-484-3300 · XenonCares@xenon-pharma.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06775379.