At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Esketamine 56 mg, Esketamine 84 mg, and 1 other intervention for Depressive Disorder, Treatment-Resistant. Completed, enrolled 477 participants across 54 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).
Study Details
Timeline
Interventions
Esketamine 56 mg will be self administered as nasal spray.
Esketamine 84 mg will be self administered as nasal spray.
Matching placebo will be self administered as nasal spray.