Introduction
anger, stress disorder, psychiatric, PTSD, depression
DISORDER, SECONDARY
Posttraumatic stress disorder (PTSD) is a common and frequently disabling psychiatric disorder often treated with psychopharmacologic agents. Most veterans with PTSD in the Veterans Administration (VA) are treated with psychotropics, most commonly selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors, trazodone, prazosin, benzodiazepines, and antipsychotics.Dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is associated with stress-related psychiatric disordersThe proposed mechanism of action has been hypothesized to reflect a resetting of the HPA axis through the restoration of the balance of the corticosteroid receptorsOwing to HPA axis dysregulation and enhanced GR sensitivity in PTSD,The primary objective of this study was to compare the clinical response to mifepristone (600 mg/d for 1 week) and placebo in male veterans with PTSD to see if there is a signal (detected by ranking and selection statistical theory); a positive signal would justify hypothesis testing in a subsequent phase 3 trial. The secondary objectives were to characterize the trajectories of PTSD symptoms during the study and evaluate safety and tolerability. For descriptive purposes, the effects on associated clinical (depression, sleep quality, and anger) and laboratory (cortisol, ACTH, and mifepristone levels) parameters were characterized.