Safety outcomes of ketamine for treatment-resistant depression in clinical settings and development of the ketamine side effect tool-revised (KSET-R).
Adam Bayes, Thanh Vinh Cao, Ana Rita Barreiros, Clara Massaneda-Tuneu, Vanessa Dong, Nicollette Thornton, Nicholas Glozier, Laura Beesley, Dalia Moreno, Verònica Gálvez-Ortiz, Brooke L Short, Donel Martin, Colleen Loo
Psychiatry Research February 1, 2025 DOI: 10.1016/j.psychres.2024.116334 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective observational study Peer reviewed |
|---|---|
| Population | Patients receiving ketamine or esketamine treatment for treatment-resistant depression in three outpatient services |
| Intervention | intranasal esketamine |
| Topics | Depression Ketamine Esketamine |
| Keywords | Adverse events Side-effects Tolerability Depression therapy Ketamine treatment Mental health safety Clinical research Adverse event monitoring |
| Citations | 6 |
| Key findings | The Ketamine Side Effect Tool-Revised (KSET-R) is a shorter, validated tool with improved feasibility for monitoring ketamine side effects in clinical settings. |
Abstract
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.
Comparable studies
Other observational and cohort studies on ketamine for depression, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Concomitant BDNF and sleep slow wave changes indicate ketamine-induced plasticity in major depressive disorder Patients with treatment-resistant major depressive disorder | 2012 | Observational cohort | n = 30 |
| Altered peripheral immune profiles in treatment-resistant depression: response to ketamine and prediction of treatment outcome Healthy controls and actively depressed patients with treatment-resistant depression... | 2017 | Observational cohort | n = 59 |
| Clinical Predictors of Ketamine Response in Treatment-Resistant Major Depression Treatment-resistant inpatients with DSM-IV-TR-diagnosed major depressive disorder or... | 2014 | Post hoc analysis of pooled data from four studies | n = 108 |
| An investigation of amino-acid neurotransmitters as potential predictors of clinical improvement to ketamine in depression Drug-free patients with major depressive disorder | 2011 | Observational cohort | n = 14 |
| Efficacy of ketamine therapy in the treatment of depression Drug-free/naïve men with severe depression, no history of psychotic disorder, head... | 2019 | Observational cohort | n = 25 |