A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Not Applicable
Recruiting
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT07076407
- Lead Sponsor
- Xenon Pharmaceuticals Inc.
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azetukalner Azetukalner Azetukalner 20 mg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6 Baseline to Week 6
- Secondary Outcome Measures
Name Time Method Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6 Baseline to Week 6 Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1 Baseline to Week 1 Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6 Baseline to Week 6
Trial Locations
- Locations (3)
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Delricht Research
🇺🇸Atlanta, Georgia, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
California Neuroscience Research🇺🇸Sherman Oaks, California, United States