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.
Are we repeating mistakes of the past? A review of the evidence for esketamine
Mark Abie Horowitz and Joanna Moncrieff
May 27, 2020