Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial.

ABSTRACT:

Importance

Approximately one-third of patients with major depressive disorder (MDD) do not respond to available antidepressants.

Objective

To assess the efficacy, safety, and dose-response of intranasal esketamine hydrochloride in patients with treatment-resistant depression (TRD).

Design, setting, and participants

This phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study was conducted in multiple outpatient referral centers from January 28, 2014, to September 25, 2015. The study consisted of 4 phases: (1) screening, (2) double-blind treatment (days 1-15), composed of two 1-week periods, (3) optional open-label treatment (days 15-74), and (4) posttreatment follow-up (8 weeks). One hundred twenty-six adults with a DSM-IV-TR diagnosis of MDD

SUBMITTER: Daly EJ 

PROVIDER: S-EPMC5838571 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature