Are we repeating mistakes of the past? A review of the evidence for esketamine

Br J Psychiatry. 2021 Nov;219(5):614-617. doi: 10.1192/bjp.2020.89.

Abstract

Esketamine has been licensed for 'treatment-resistant depression' in the USA, UK and Europe. Licensing trials did not establish efficacy: two trials were negative, one showed a statistically significant but clinically uncertain effect, and a flawed discontinuation trial was included, against Food and Drug Administration precedent. Safety signals - deaths, including suicides, and bladder damage - were minimised.

Keywords: Esketamine; antidepressants; depression; ketamine; suicide.

Publication types

  • Review

MeSH terms

  • Antidepressive Agents / adverse effects
  • Depressive Disorder, Treatment-Resistant* / drug therapy
  • Humans
  • Ketamine* / adverse effects
  • Suicide*

Substances

  • Antidepressive Agents
  • Esketamine
  • Ketamine