The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry

• Authors: Patricio Riva Posse, Emory University; Adam Bayes, Black Dog Institute, UNSW Sydney, Australiaey; Brooke Short, St Vincent’s Hospital, Sydney, Australia; Carlos A Zarate, Division of Intramural Research Program, National Institute of Mental Health, MD, United States; Lawrence Park, Division of Intramural Research Program, National Institute of Mental Health, MD, United States; James W Murrough, Depression and Anxiety Centre for Discovery and Treatment, Icahn School of Medicine at Mount Sinai, New York, NY, United States; Declan M McLoughlin, Department of Psychiatry, Trinity College Institute of Neuroscience, Trinity College, Dublin, Ireland; Patricio Riva-Posse, Emory University; Robert Schoevers, The University Medical Center Groningen, Groningen, the Netherlands; Jolien Veraart, The University Medical Center Groningen, Groningen, the Netherlands; Sagar Parikh, University of Michigan; Paul Glue, University of Otago, Dunedin, New Zealand; Johnson Fam, Department of Psychological Medicine, National University Hospital, Singapore; Rupert McShane, University of Oxford; Veronica Galvez, Corporacio Sanitaria Parc Tauli, Universitat Autonoma de Barcelona, I3PT, Institut d’Investigacio i Innovacio Parc Tauli, Sabadell, Barcelona, Spain; Donel Martin, Black Dog Institute, UNSW Sydney, Australia; Phern-Chern Tor, Institute of Mental Health, Singapore; Andre Brunoni, Laboratory of Neurosciences (LIM-27), Institute of Psychiatry, Hospital das Clínicas da Faculdade de Medicina da USP, Brazil; Colleen K Loo, Black Dog Institute, UNSW Sydney, Australia
• Journal Title: JOURNAL OF AFFECTIVE DISORDERS
• Volume: Volume 308
• Publisher: ELSEVIER | 2022-04-13, Pages 44-46
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.jad.2022.04.020
• Subjects: Health Sciences, Medicine and Surgery; Biology, Neuroscience; Psychology, Clinical; Health Sciences, Mental Health
• Keywords: Science & Technology; Life Sciences & Biomedicine; Clinical Neurology; Psychiatry; Neurosciences & Neurology; Antidepressant; Safety; Side effects; Maintenance; DOUBLE-BLIND; DEPRESSION; METAANALYSIS; EFFICACY

Abstract

Objectives: On a background of the rapidly expanding clinical use of ketamine and esketamine for treatment of depression and other conditions, we examined safety monitoring, seeking to identify knowledge gaps relevant to clinical practice. Methods: An international group of psychiatrists discussed the issue of safety of ketamine and esketamine and came to a consensus on key safety gaps. Results: There is no standard safety monitoring for off-label generic ketamine. For intranasal esketamine, each jurisdiction providing regulatory approval may specify monitoring. Treatment is often provided beyond the period for which safety has been demonstrated, with no agreed framework for monitoring of longer term side effects for either generic ketamine or intranasal esketamine. Limitations: The KSET has established face and content validity, however it has not been validated against other measures of safety. Conclusions: We recommend the Ketamine Side Effect Tool (KSET) as a comprehensive safety monitoring tool for acute and longer term side effects.