A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Sponsored by Xenon Pharmaceuticals Inc.
About this study
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)
Where this study is enrolling (2)
- I'm interested
Delricht Research
Atlanta, Georgia
- I'm interested
Emory University Brain Health Center
Atlanta, Georgia
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.