An Open-Label Study of Doxazosin Extended-Release for PTSD: Findings and Recommendations for Future Research on Doxazosin.

OBJECTIVE:This report presents findings from an eight-week, open-label study of doxazosin extended-release for nightmares, sleep disturbance, and overall clinical symptoms in posttraumatic stress disorder (PTSD). Recommendations for future studies of doxazosin are provided. METHOD:Fifteen male and female adults were enrolled. The primary endpoints were change in Clinician-Administered PTSD Scale total, nightmare, and sleep disturbance scores from pretreatment to end of treatment. Self-report data on PTSD, sleep quality, depression, and quality of life collected at three time points and sleep diary data collected daily were analyzed secondarily. RESULTS:Eight participants completed eight weeks of study treatment. Among completers, significant changes in nightmares and overall PTSD symptoms were found. Secondary analyses using data from completers and noncompleters demonstrated improvements in all secondary outcomes. Of the participants who dropped out of the study, four participants discontinued because of side effects, and three participants discontinued because of other barriers to study participation. CONCLUSIONS:These findings indicate that doxazosin may be of value for some individuals with PTSD but problematic for others. Alternative formulations of doxazosin, such as the immediate-release formulation, should be studied. Future research should examine moderators of treatment tolerability and treatment effects to best identify those who will or will not benefit from doxazosin.