clinical trial · NCT07716098
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
Janssen Research & Development, LLC·phase3·recruiting·n = 348
Depressive Disorder, Treatment-ResistantEsketamine 56 mgEsketamine 84 mgPlacebo
brief 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).
started
Jul 23, 2026
primary completion
Dec 27, 2028
completion
Sep 12, 2029
last updated
Aug 28, 2026
official title
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol