Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Led by Xenon Pharmaceuticals Inc. · Updated on 2025-10-22
450
Participants Needed
46
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD in this Phase 3, multicenter, randomized, double-blind, placebo-controlled study. The trial aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD, focusing on changes in depression severity over a 6-week treatment period. Participants will receive either azetukalner 20 mg or a matching placebo, taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study includes a screening period of approximately 4 weeks before baseline and monitors participants through 8 weeks after the final dose to assess safety. The trial is designed with two treatment arms and uses quadruple masking to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S scale. Safety and tolerability are evaluated throughout the study and follow-up periods by monitoring adverse events. Overall participation lasts from screening through 8 weeks post-treatment, with close attention to depression symptoms and participant well-being.
CONDITIONS
Brief Title
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 74 years of age
- Experienced first major depressive episode before age 50
- Body Mass Index (BMI) of 40 kg/m2 or less
- Meets DSM-5-TR criteria for current major depressive disorder and is currently in a major depressive episode confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Current major depressive episode duration between 6 weeks and 24 months
You will not qualify if you...
- Primary diagnosis of mood disorder other than Major Depressive Disorder
- History of 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 disorders
- Current diagnosis of MDD with seasonal pattern, depression with peripartum or perimenopausal onset, post traumatic stress disorder, antisocial or borderline personality disorder, panic disorder and/or agoraphobia, or ADHD treated with psychostimulants during current episode or unstable symptoms
- Substance or alcohol use disorder within 12 months prior to screening (excluding tobacco)
- Active suicidal plan or intent within 6 months prior to screening, suicidal behavior in last 2 years, or more than one suicide attempt after age 24
- History of non-suicidal self-harm behavior within 12 months prior to screening
- Use of antidepressants or prohibited medications within 2 weeks (4 weeks for fluoxetine) or within less than 5 times the drug's half-life prior to randomization
- History of non-response to two or more antidepressant drugs during current major depressive episode
- Medical conditions interfering with study purposes or conduct
- Pregnant, breastfeeding, or planning pregnancy
Research Team
X
Xenon Medical Affairs
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