The goal of this pilot study was to evaluate the effect of
dehydroepiandrosterone (
DHEA) on depressed mood and
fatigue in HIV+ men and women, unselected for baseline
DHEA level. Secondary questions concerned treatment effects on libido and body cell mass, on serum
testosterone levels, and elicitation of short-term side effects. Treatment consisted of an open-label 8-week trial using
DHEA doses from 200 to 500 mg/day. Mood responders were maintained for another 4 weeks, then randomized to a double blind placebo controlled 4-week discontinuation trial. Forty-five patients, including six women, entered the trial. Of 32 week 8 completers, mood was much improved in 72%, and 81% were rated responders with respect to
fatigue. Response on either parameter was unrelated to baseline serum
DHEA level. Twenty-one patients entered the double blind discontinuation phase. No differences in relapse rate between placebo and
DHEA groups were observed for either mood or
fatigue. Body cell mass increased significantly by week 8, and this improvement was maintained throughout the double blind phase for patients in both treatment conditions. Libido increased significantly as well.
DHEA therapy did not have an effect on CD4 cell count or on serum
testosterone levels in men. In conclusion,
DHEA may be a promising treatment for HIV+ patients with depressed mood and
fatigue, although persistence of response even in placebo-treated patients during the discontinuation phase leaves unresolved questions. A parallel group double blind clinical trial is indicated as the next step to more clearly identify therapeutic efficacy.