Clinical Trial

A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression

Recruiting Phase 3
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Summary
The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[MDD\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-08-01
notable Trial sites expanded: 1 -> 4 locations 2026-08-01
Trial Details
NCT Number NCT07716098
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Treatment-Resistant
Enrollment 348 participants
Start Date 2026-07-27
Primary Completion 2028-12-27 (estimated)
Study Completion 2029-09-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-31