Ketamine Safety and Tolerability in Clinical Trials for Treatment-Resistant Depression

Summary & key facts

Researchers pooled results from 205 intravenous ketamine infusions (0.5 mg/kg given over 40 minutes) in 97 people with treatment-resistant major depression. About two thirds (67%, 65 of 97) showed a strong antidepressant response (≥50% improvement). Most side effects happened in the first 4 hours and were short-lived. Few infusions were stopped for safety reasons and the authors said ketamine was generally safe and well tolerated in this group, while noting more safety research is needed.

Key facts:

• The analysis combined 205 IV ketamine infusions given to 97 participants with DSM-IV major depressive disorder.
• Dose and infusion time used in these trials were 0.5 mg/kg administered over 40 minutes.
• Antidepressant response (≥50% improvement on the Montgomery–Åsberg scale) occurred in 67% of participants (65 of 97).
• Four of 205 infusions (1.95%) were discontinued because of adverse events.
• Overall study attrition was 3.1% (3 of 97 participants).
• Common adverse events in the first 4 hours were drowsiness, dizziness, poor coordination, blurred vision, and feeling strange or unreal.
• About one third of patients experienced protocol-defined hemodynamic changes (changes in blood pressure or heart rate).
• Ketamine produced small but statistically significant increases in psychotomimetic (psychosis-like) and dissociative (feeling detached or unreal) symptoms (all P < .05).
• In the subgroup with available long-term follow-up data, there were no reports of persistent psychotomimetic effects, no reported adverse medical effects, and no increase in substance use.
• The pooled data came from three clinical trials run between 2006 and 2012 at two academic medical centers (ClinicalTrials.gov identifiers: NCT00419003, NCT00548964, NCT00768430).

Abstract

ClinicalTrials.gov identifiers: NCT00419003, NCT00548964, and NCT00768430.

Topics

Mental Health Research Topics Treatment of Major Depression Tryptophan and brain disorders

Categories

Health Sciences Medicine Pharmacology

Tags

Adverse effect Anesthesia Antidepressant Anxiety Cognition Dissociative Internal medicine Ketamine Major depressive disorder Medicine NMDA receptor Psychiatry Psychology Psychotomimetic Receptor Tolerability Treatment-resistant depression