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Background <p>Fatigue, a prevalent symptom of chronic illness, impacts quality of life. This proof-of-concept, randomized, double-blind, crossover trial assessed the anti-fatigue effects of ketamine (0.5&#xa0;mg/kg) versus midazolam (0.045&#xa0;mg/kg), the active comparator.</p> Methods <p>Ten participants, who were cancer survivors, with fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome, or systemic lupus erythematosus, were randomized into Arm 1 (n = 4, Period 1: ketamine to Period 2: midazolam) or Arm 2 (n = 6, Period 1: midazolam to Period 2: ketamine).</p> Results <p>The two periods were separately analyzed because of carryover effects with baseline fatigue scores, assessed by the fatigue visual analog scale (VAS), between the study periods (<i>p</i> = 0.03). Looking at changes in fatigue VAS scores from baseline (pre-infusion) to 3&#xa0;days post-infusion, the ketamine group had a 21.0% decrease in Period 1 and 10.9% in Period 2, while the midazolam group showed a 17.7% decrease in Period 1 and 12.6% in Period 2. We did not observe a statistically significant difference in both periods. The largest fatigue score reduction for the ketamine group was at 1 day post-infusion, at − 38.7% in Period 1.</p> Conclusion <p>Despite no statistical significance, a reduction in real-time fatigue scores was observed, which exceeded the 20% efficacy threshold, the primary outcome, in the ketamine arm from pre-infusion to 3&#xa0;days post-infusion. The carryover effects and the peak reduction in fatigue at 24&#xa0;hours after ketamine administration suggest that future trials may need to consider a study design without cross-over and an optimal active placebo alternative.</p>

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A preliminary proof-of-concept trial on the effects of ketamine on fatigue: a randomized crossover trial

  • 期刊论文

  • 发表日期：

    2026年1月22日

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  • Taichi Goto,
  • Joy D. Kreskow,
  • Alexander L. R. Ross,
  • Catherine L. Blumhorst,
  • Justin J. Zhao,
  • Andrew J. Mannes,
  • Miroslav Bačkonja,
  • Carlos A. Zarate Jr,
  • Leorey N. Saligan

摘要

Background

Fatigue, a prevalent symptom of chronic illness, impacts quality of life. This proof-of-concept, randomized, double-blind, crossover trial assessed the anti-fatigue effects of ketamine (0.5 mg/kg) versus midazolam (0.045 mg/kg), the active comparator.

Methods

Ten participants, who were cancer survivors, with fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome, or systemic lupus erythematosus, were randomized into Arm 1 (n = 4, Period 1: ketamine to Period 2: midazolam) or Arm 2 (n = 6, Period 1: midazolam to Period 2: ketamine).

Results

The two periods were separately analyzed because of carryover effects with baseline fatigue scores, assessed by the fatigue visual analog scale (VAS), between the study periods (p = 0.03). Looking at changes in fatigue VAS scores from baseline (pre-infusion) to 3 days post-infusion, the ketamine group had a 21.0% decrease in Period 1 and 10.9% in Period 2, while the midazolam group showed a 17.7% decrease in Period 1 and 12.6% in Period 2. We did not observe a statistically significant difference in both periods. The largest fatigue score reduction for the ketamine group was at 1 day post-infusion, at − 38.7% in Period 1.

Conclusion

Despite no statistical significance, a reduction in real-time fatigue scores was observed, which exceeded the 20% efficacy threshold, the primary outcome, in the ketamine arm from pre-infusion to 3 days post-infusion. The carryover effects and the peak reduction in fatigue at 24 hours after ketamine administration suggest that future trials may need to consider a study design without cross-over and an optimal active placebo alternative.