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Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue.

Authors
  • Fitzgerald, Kathryn C1
  • Morris, Bridget2
  • Soroosh, Aurash2
  • Balshi, Alexandra2
  • Maher, Dermot3
  • Kaplin, Adam4
  • Nourbakhsh, Bardia2
  • 1 Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA/Department of Epidemiology, Johns Hopkins University School of Public Health, Baltimore, MD, USA.
  • 2 Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • 3 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • 4 Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Type
Published Article
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
Publication Date
May 01, 2021
Volume
27
Issue
6
Pages
942–953
Identifiers
DOI: 10.1177/1352458520936226
PMID: 32633662
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Fatigue is the most common symptom of MS and has no effective pharmacotherapy. To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for 7 days following the infusion. Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models. In total, 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after 7 days (-0.10 point; 95% confidence interval (CI): -0.32, 0.12; p = 0.40). We observed a trend in reduced FSS scores at 1 week (-5.2 points; 95% CI: -10.4, 0.14; p = 0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (-13.5 point; 95% CI: -25.0, -1.98; p = 0.04). Ketamine infusions were safe and well-tolerated. While no change in DFS after 7 days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer term fatigue severity in people with MS.

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