Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence
Nelson B Rodrigues, Roger S McIntyre, Orly Lipsitz, Yena Lee, Danielle S. Cha, Flora Nasri, Hartej Gill, Leanna M.W. Lui, Mehala Subramaniapillai, Kevin Kratiuk, Kangguang Lin, R. Ho, Rodrigo B. Mansur, Joshua D. Rosenblat
Expert Opinion on Drug Safety June 15, 2020 DOI: 10.1080/14740338.2020.1776699 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective observational study Peer reviewed |
|---|---|
| Sample size | 203 |
| Population | Patients with treatment-resistant depression receiving repeat-dose IV ketamine in community-based clinics |
| Intervention | Intravenous ketamine |
| Topics | Depression Esketamine Ketamine |
| Citations | 50 |
| Key findings | Intravenous ketamine was safe and well-tolerated in community-based treatment of treatment-resistant depression, with hypertension commonly observed but transient, and no cases of psychosis, mania, or new onset suicidality. |
Abstract
ABSTRACT Objectives Rigorous clinical trials suggest ketamine is safe and well-tolerated in patients with treatment-resistant depression (TRD). There is a paucity of data on the safety and tolerability of ketamine in community-based clinics treating patients with TRD.
Methods: Retrospective data was analyzed from 203 patients with TRD who received repeat-dose IV ketamine. Safety was operationalized as hemodynamic changes. Tolerability was evaluated through the reporting of adverse events and dissociation symptom severity, as measured by the Clinician-Administered Dissociative States Scale.
Results: Ketamine was well-tolerated, with less than 5% of patients withdrawing due to tolerability concerns. Blood pressure significantly increased during infusion, with 44.3% meeting criteria for treatment-emergent hypertension (i.e., blood pressure ≥ 165/100 mmHg). 12% of patients exhibiting hypertension required pharmacological intervention. The most frequently reported adverse events included drowsiness (56.4%), dizziness (45.2%), dissociation (35.6%), and nausea (13.3%). Dissociation severity significantly attenuated after the first infusion, but plateaued for subsequent infusions.
Conclusion: Intravenous ketamine was safe and well-tolerated. Hypertension was commonly observed and was often transient. Dissociation was most frequently reported after the first infusion but remained a consistent but not treatment-limiting adverse event thereafter. No patients exhibited psychosis, mania, or new onset suicidality with IV ketamine.