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Esketamine clinical trials: reply to Maju et al.

C. Gastaldon, D. Papola, G. Ostuzzi, C. Barbui

Epidemiology and Psychiatric Sciences 2020 DOI: 10.1017/s204579602000027x (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Commentary Peer reviewed
Topics Esketamine
Key points The authors argue for critically examining the evidence base needed to obtain regulatory approval for esketamine, in reply to Maju et al.'s clarifications about esketamine clinical trial data and the debate following its marketing authorization. The text does not state specific findings or conclusions beyond this framing.

Abstract

Abstract Maju et al. provided clarifications on important and controversial issues related to esketamine clinical trial data, in response to a vivid debate triggered by the marketing authorisation recently granted by this new medicine. In this commentary, we reply to their comments attempting to critically discuss the evidence base needed to obtain regulatory approval.