Are we repeating mistakes of the past? A review of the evidence for esketamine
Mark Horowitz, Joanna Moncrieff
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.
Topics & Concepts
DiscontinuationFood and drug administrationDepression (economics)MedicineClinical trialKetamineTreatment-resistant depressionDrug trialPsychiatryIntensive care medicinePsychologyInternal medicineMajor depressive disorderPharmacologyCognitionMacroeconomicsEconomicsTreatment of Major DepressionNeurotransmitter Receptor Influence on BehaviorElectroconvulsive Therapy Studies