Julia Golier, M.D.; James J. Peters Veterans Administration Medical Center; GWIRP Investigator-Initiated Research Award

The problem that we are addressing is a condition called chronic multisymptom illness in Gulf War veterans. That's the current case-definition for what is commonly known as Gulf War Illness. Gulf War Illness describes an array of symptoms that are very highly prevalent in veterans of the 1991 Gulf War that can include headaches, memory disturbance, generalized muscle pain, weakness and fatigue. Currently there are no known specific treatments for Gulf War Illness or Chronic Multisymptom Illness which is of concern because this is a distressing and disabling condition that seems to persist over time. We're studying a medication called mifepristone which is a glucocorticoid receptor antagonist because we think it will alter some of the biological alterations that we have found to be associated with Gulf War deployment and Gulf war exposures. So we think that by altering this biological system we can hopefully achieve improvement in clinical health and neuropsychological outcomes. Clinical trials in this area are critical because currently there really are no treatments for Gulf War Illness that specifically target the biological abnormalities that have been found in Gulf War veterans. We are attempting to find a clinical solution at the same time we are continuing to investigate the biology of the illness, how the medication affects some of these biological alterations so that we'll understand if this medication effective and if so really begin to appreciate what kind of mechanisms are involved in recovery and in the illness itself. So we think this will have an important impact and provide a proof of concept as to whether or not glucocorticoid receptor antagonism can have therapeutic benefits in Gulf War veterans. We're heartened by the fact that a variety of animal studies have shown that mifepristone has a neuro-protective effect in human studies that have shown beneficial effects in mood, sleep, cognitive functioning and other neuropsychiatric disorders. Our main goal is to see whether or not mifepristone improves physical health but also to look at cognitive functioning, and neuropsychological deficits are very common in Gulf War veterans. Multiple objective studies have shown deficits in the area of speed of processing memory and attention and this can really adversely impact day-to-day life. So one of our outcomes is objective neuropsychological testing as well as mental health in Gulf War veterans. The CDMRP has been extremely supportive and this trial would not have happened without them. We designed this trial in direct response to one of their requests for proposals. They put out announcements looking specifically for Gulf War clinical trials which would really not have been probably supported under any other mechanism. So their involvement has really been critical in launching this and other clinical trials in Gulf War veterans. This research would not be happening without them.