Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial.

ABSTRACT:

Importance

Esketamine nasal spray, administered in conjunction with an oral antidepressant, is approved for treatment-resistant depression (TRD). However, the efficacy of esketamine nasal spray administered as monotherapy for patients with TRD has not yet been evaluated.

Objective

To assess the efficacy and safety of esketamine monotherapy compared to placebo in reducing depressive symptoms in patients with TRD.

Design, setting, and participants

This phase 4, double-blind, placebo-controlled randomized clinical trial was conducted from November 2020 to January 2024 at 51 outpatient centers in the US. Adults with major depressive disorder (DSM-5 criteria) without psychotic features who experienced inadequate response (≤25% improvement) to 2 or more oral antidepressants

SUBMITTER: Janik A 

PROVIDER: S-EPMC12224050 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature