European Journal of Psychotraumatology (Sep 2012)

A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness

  • Julia A. Golier,
  • Kimberly Caramanica,
  • James Schmeidler,
  • Philip D. Harvey,
  • Rachel Yehuda

DOI
https://doi.org/10.3402/ejpt.v3i0.19474
Journal volume & issue
Vol. 3, no. 0
pp. 1 – 1

Abstract

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Background : Nearly 34–65% of Gulf War veterans (GWV) continue to suffer from chronic multisymptom illness (CMI); novel pharmacological treatment approaches are needed to improve the health of these veterans. This study aims to determine whether mifepristone, a glucocorticoid receptor antagonist, can reverse the neuroendocrine alterations described in GWV and improve the physical health, mental health, and neurocognitive functioning of GWV with CMI. Methods : Sixty-five GWV were enrolled into the study; 36 eligible GWV who met criteria for CMI and did not have any exclusionary medical or psychiatric conditions were randomized to receive mifepristone (200 mg/day) or matched placebo first in this crossover study. Both treatment phases lasted 6 weeks and were separated by a 4-week wash-out period. The primary clinical outcome measure was the change from treatment baseline to treatment endpoint in the physical health component score (PCS) of the veterans SF-36 health survey. Primary neurocognitive outcome measures included change in spatial working memory and verbal declarative memory as measured by the MATRICS Consensus Cognitive Battery. Additional outcome measures included change in the mental health components score (MCS) of the SF-36 and self-reported symptoms of fatigue, depression, and PTSD. Cortisol and ACTH levels and a measure of glucocorticoid sensitivity (lysozyme IC50-DEX) were also obtained to characterize the neuroendocrine response to mifepristone in GWV with CMI. Results : Data collection is complete; results regarding the primary and secondary clinical, neuropsychological, and neuroendocrine outcome measures will be presented. Conclusion : If this study shows that mifepristone improves physical health or cognition or reduces constituent symptoms of CMI in GWV, it would suggest that mifepristone may be of therapeutic value in this population.

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