A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

What this Trial Is About

Researchers are evaluating azetukalner as a treatment for adults diagnosed with Moderate-to-Severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical effectiveness, safety, and tolerability of azetukalner when used alone in adults aged 18 to 74 years who are currently experiencing a major depressive episode. The study is sponsored by Xenon Pharmaceuticals Inc. and focuses on improving depressive symptoms over a six-week period. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo once daily, taken orally with food, preferably with the evening meal. Treatment lasts for six weeks, during which the effects of the medication will be closely monitored. The study uses a quadruple-blind design, meaning that participants, care providers, investigators, and outcome assessors will not know which treatment is given to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale HAMD-17 to measure changes in depression severity from baseline to Week 6, along with other scales like the Snaith-Hamilton Pleasure Scale SHAPS and Clinical Global Impression of Severity CGI-S. Safety and tolerability will be monitored from about four weeks before treatment through eight weeks after the final dose. The total participation duration covers treatment and follow-up to evaluate both short-term effects and safety outcomes.

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)