Limitations
TBI, PTSD
EVENT
This study has some limitations. Notably, it applies only to men. Insofar as mifepristone is an abortifacient, the risk profile would be different in women owing to its antiprogesterone effects. A separate study in women with PTSD accounting for these risks may be warranted.This study was restricted to a single dose (600 mg) owing to the termination of the 1200-mg dose arm following an unanticipated event. A higher dose or longer duration of treatment might have yielded more participants with a better clinical response. If future studies are conducted, a broader range of doses should be considered to allow for a wider range of mifepristone levels and determine whether there is a relationship between drug level and outcome in PTSD.This sample may not be generalizable to the larger population of treatment-seeking veterans in the VA system. More than half were excluded because of stringent medical and concomitant medication exclusions. Additionally, there was a high prevalence of lifetime history of TBI. Given the poor response in veterans with TBI to mifepristone, this may have contributed to the lack of efficacy in the overall trial.