Adam Bayes1, Brooke Short2, Carlos A Zarate3, Lawrence Park3, James W Murrough4, Declan M McLoughlin5, Patricio Riva-Posse6, Robert Schoevers7, Jolien Veraart7, Sagar Parikh8, Paul Glue9, Johnson Fam10, Rupert McShane11, Veronica Galvez12, Donel Martin13, Phern-Chern Tor14, Andre R Brunoni15, Colleen K Loo16. 1. Black Dog Institute, UNSW Sydney, Australia; School of Psychiatry, UNSW Sydney, Australia. Electronic address: a.bayes@unsw.edu.au. 2. St Vincent's Hospital, Sydney, Australia. 3. Division of Intramural Research Program, National Institute of Mental Health, MD, United States. 4. Depression and Anxiety Centre for Discovery and Treatment, Icahn School of Medicine at Mount Sinai, New York, NY, United States. 5. Department of Psychiatry, Trinity College Institute of Neuroscience, Trinity College, Dublin, Ireland. 6. Department of Psychiatry and Behavioral Sciences at Emory University, Atlanta, GA, United States. 7. The University Medical Center Groningen, Groningen, the Netherlands. 8. Department of Psychiatry, University of Michigan, MI, United States. 9. University of Otago, Dunedin, New Zealand. 10. Department of Psychological Medicine, National University Hospital, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore. 11. Department of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, United Kingdom. 12. Corporacio Sanitaria Parc Tauli, Universitat Autonoma de Barcelona, I3PT, Institut d'Investigacio i Innovacio Parc Tauli, Sabadell, Barcelona, Spain. 13. Black Dog Institute, UNSW Sydney, Australia. 14. Institute of Mental Health, Singapore. 15. Laboratory of Neurosciences (LIM-27), Institute of Psychiatry, Hospital das Clínicas da Faculdade de Medicina da USP, Brazil. 16. Black Dog Institute, UNSW Sydney, Australia; School of Psychiatry, UNSW Sydney, Australia.
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.
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.
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