@article{936b27d056a444f5938a53d56b3b54f6,
title = "The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry",
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.",
keywords = "Antidepressant, Maintenance, Safety, Side effects",
author = "Adam Bayes and Brooke Short and Zarate, {Carlos A.} and Lawrence Park and Murrough, {James W.} and McLoughlin, {Declan M.} and Patricio Riva-Posse and Robert Schoevers and Jolien Veraart and Sagar Parikh and Paul Glue and Johnson Fam and Rupert McShane and Veronica Galvez and Donel Martin and Tor, {Phern Chern} and Andre Brunoni and Loo, {Colleen K.}",
note = "Funding Information: All of the authors (except for SP, LP, PCP, PG, Andre Brunoni) were involved in the development of the KSET. Adam Bayes, BS, VG, PR-P, JF and CL declare no conflicts of interest. CAZ is listed as a co-inventor on a patent for the use of ketamine in major depression and suicidal ideation. CAZ is listed as co-inventor on a patent for the use of (2R,6R)- hydroxynorketamine, (S)-dehydronorketamine, and other stereo- isomeric dehydro and hydroxylated metabolites of (R,S)-ketamine metabolites in the treatment of depression and neuropathic pain; and as co-inventor on a patent application for the use of (2R,6R)-hydroxynorketamine and (2S,6S)-hydroxynorketamine in the treatment of depression, anxiety, anhedonia, suicidal ideation, and posttraumatic stress disorders. He has assigned his patent rights to the US government but will share a percentage of any royalties that may be received by the government. Declan McLoughlin has received speaker{\textquoteright}s honoraria from MECTA, Otsuka and Janssen and an honorarium from Janssen for participating in an esketamine advisory board meeting. RS received research funding for 2 randomized clinical trials with generic oral esketamine from the Netherlands Organisation for Health Research & Development and the National Health Care Institute, a speakers fee from Janssen Pharmaceuticals, and consultancy fee from Clexio biosciences, both outside the submitted work. JV received a speakers fee from Janssen Pharmaceuticals, outside the submitted work. PG has within the last three years has had a research contract with Douglas Pharmaceuticals for developing a ketamine tablet, and is named on a patent; he has attended a Janssen Pharmaceuticals advisory board. RM{\textquoteright}s department has received funds from Janssen for Scientific Advisory Board meetings. Donel Martin undertook consultancy work for Douglas Pharmaceuticals for a ketamine study. TPC has received honorarium from J&J to be a local advisory board for ESK. Andre Brunoni receives grants from S{\~a}o Paulo Research State Foundation FAPESP (2019/06009-6) and Academy of Medical Sciences (NAFR 12/1010). He also receives in-kind support from Soterix Medical, Flow Neuroscience, and Magventure. Publisher Copyright: {\textcopyright} 2022 Elsevier B.V.",
year = "2022",
month = jul,
day = "1",
doi = "10.1016/j.jad.2022.04.020",
language = "English",
volume = "308",
pages = "44--46",
journal = "Journal of Affective Disorders",
issn = "0165-0327",
publisher = "Elsevier",
}