A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
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
Janssen Research & Development, LLC
348 participants
Jul 23, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
Participants will self-administer placebo as intranasal spray into each nostril.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07716098