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

Xenon Pharmaceuticals Inc.
NCT IDNCT07076407ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

450

Study length

about 2.1 years

Ages

18–74

Locations

35 sites in AL, AR, CA +15

About this study

Researchers are testing a treatment called azetukalner versus a placebo for people with major depressive disorder. The trial will last about 753 days and involve around 450 participants.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Azetukalner
  • 2.Take Placebo
PhasePhase 3
Primary goalChange from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low10%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

Primary: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

Secondary: Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6, Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1, Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6, To assess the safety and tolerability of azetukalner (e.g., adverse events)

Body systems

Psychiatry / Mental Health