A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Launched by XENON PHARMACEUTICALS INC. · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial, called X-NOVA2, is studying a new medication called azetukalner to see how well it works for adults with Major Depressive Disorder (MDD). The trial is designed for adults aged 18 to 74 years who have experienced their first major depressive episode before turning 50. Participants must currently be dealing with a major depressive episode that has lasted between 6 weeks and 24 months. To be eligible, they should not have other mood disorders or certain mental health issues, and they should not have used specific medications in the weeks leading up to the trial.

During the trial, participants will be randomly assigned to receive either azetukalner or a placebo (a pill with no active medication) for comparison. The study is double-blind, meaning neither the participants nor the researchers will know who is getting the actual medication and who is getting the placebo, which helps ensure the results are unbiased. Participants can expect regular check-ins to monitor their health and how they’re feeling throughout the study. This is an important opportunity to help researchers understand if azetukalner can be an effective treatment for people struggling with depression.

Gender

ALL

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 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.