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Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: A randomized clinical trial

JAMA Jun 12, 2019

Daly EJ, et al. - Through a phase 3, multicenter, double-blind, randomized withdrawal study of 297 adult patients with treatment-resistant depression (TRD) in stable remission post induction and optimization course of esketamine nasal spray plus an oral antidepressant, the researchers targetted to assess the efficacy of esketamine nasal spray plus an oral antidepressant in comparison to an oral antidepressant plus placebo nasal spray in delaying relapse of depressive symptoms. Transient dysgeusia, vertigo, dissociation, somnolence, and dizziness were the most common adverse events reported for esketamine-treated patients after randomization. TRD patients who received esketamine treatment and experienced remission or response, a clinically meaningful superiority in delaying relapse compared with an antidepressant plus placebo after the resumption of esketamine nasal spray in addition to oral antidepressant treatment were concluded.
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