A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Purpose
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)
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Azetukalner |
Azetukalner 20 mg |
|
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Xenon Pharmaceuticals Inc.
