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Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence.
- Source :
-
Expert opinion on drug safety [Expert Opin Drug Saf] 2020 Aug; Vol. 19 (8), pp. 1031-1040. Date of Electronic Publication: 2020 Jun 15. - Publication Year :
- 2020
-
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.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Canada
Depressive Disorder, Treatment-Resistant drug therapy
Excitatory Amino Acid Antagonists administration & dosage
Female
Humans
Infusions, Intravenous
Ketamine adverse effects
Male
Middle Aged
Retrospective Studies
Bipolar Disorder drug therapy
Depressive Disorder, Major drug therapy
Excitatory Amino Acid Antagonists adverse effects
Ketamine administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1744-764X
- Volume :
- 19
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Expert opinion on drug safety
- Publication Type :
- Academic Journal
- Accession number :
- 32539491
- Full Text :
- https://doi.org/10.1080/14740338.2020.1776699