Safety outcomes of ketamine for treatment-resistant depression in clinical settings and development of the Ketamine Side Effect Tool-Revised (KSET-R)

• Published in: Psychiatry research 2024-12, Vol.344, p.116334, Article 116334
• Main Authors: Bayes, Adam, Cao, Thanh Vinh, Barreiros, Ana Rita, Massaneda-Tuneu, Clara, Dong, Vanessa, Thornton, Nicollette, Glozier, Nicholas, Beesley, Laura, Moreno, Dalia, Gálvez, Verònica, Short, Brooke, Martin, Donel, Loo, Colleen
• Format: Article
• Language: English
• Subjects: adverse events; depression; ketamine; side-effects; tolerability
• ISSN: 0165-1781; 1872-7123; 1872-7123
• DOI: 10.1016/j.psychres.2024.116334

•Naturalistic data from 111 patients with over 600 treatments is reported.•Frequency of SEs is reported inter-session, intra-session and at follow-up.•The Overall Tolerability rating has construct and concurrent validity.•The KSET-R is more feasible to use with high clinical utility. Ketamine and its derivates (e.g. esketamine) are increasingly used in clinical settings for treatment-resistant depression (TRD). Ketamine can give rise to acute, cumulative and longer-term side effects (SEs) across a treatment course. The Ketamine Side Effect Tool (KSET) examines adverse effects though its length has affected feasibility for use in clinical settings. To estimate the frequency of ketamine SEs occurring in real-world settings using the KSET, additional validated scales and laboratory measures. Utilising this naturalistic data, to develop a shorter, more feasible and validated tool (KSET-Revised; KSET-R). Retrospective patient and safety data from three outpatient services were collected which included KSET symptom questions, standardised scales and laboratory measures. We calculated frequency of SEs occurring intra-session, intersession and at follow-up. Revision of the KSET included removal of items based on a priori criteria. Construct and concurrent validity were examined by comparison of specific KSET items and the overall tolerability rating with standardised scales. Descriptive statistics including SE frequencies are reported and the KSET-R is detailed: a shorter tool with construct and concurrent validity for specific items, along with the overall tolerability rating. small sample size for follow-up data; predominantly subcutaneous racemic and intranasal esketamine analysed - other routes and formulations not examined; and subjective not objective cognition measured. Naturalistic data gives an estimate of frequency of ketamine SEs within session, between sessions and at follow-up. The KSET-R has improved feasibility and clinical utility and is recommended for use in clinical practice where ketamine is prescribed.