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Clinical trial

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Janssen Research & Development, LLCCompletedPhase 4Started Nov 4, 2020477 enrolledUnited StatesNCT04599855

Abstract

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).

Topics & conditions

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KetamineDepression

Keywords

Depressive Disorder, Treatment-Resistant

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