Treatment of erectile dysfunction in men with depressive symptoms: Resultsof a placebo-controlled trial with sildenafil citrate

Objective: Depressed men commonly have erectile dysfunction, and men with e rectile dysfunction are frequently depressed. Since the etiologic and modul atory relationships between depression and erectile dysfunction have been p oorly characterized, a 12-week, randomized, double-blind, placebo-controlle d trial was conducted at 20 urologic clinics to evaluate the effects of sil denafil treatment in men with erectile dysfunction and mild-to-moderate com orbid depressive illness. Method: Men(N = 152, mean age -56 years) with erectile dysfunction for grea ter than or equal to6 months (mean = 5.7 years), a DSM-IV diagnosis of depr essive disorder not otherwise specified, and a Hamilton Depression Rating S cale score greater than or equal to 12 (mean at baseline = 16.9) were rando mly assigned to flexible-dose treatment with sildenafil citrate or matching placebo. Interviewer-rated and self-report instruments were used to assess changes in sexual function, depressive symptoms, and quality of life. Cons ervative criteria were used to classify erectile dysfunction treatment resp onse and nonresponse. Results. Sildenafil was strongly associated with erectile dysfunction treat ment response. Fifty-eight men met the conservative criteria for response ( 48 given sildenafil, 10 given placebo), and 78 men did not respond (18 give n sildenafil, 60 given placebo). Mean decreases of 10.6 and 2.3 in Hamilton depression scale scores were seen in treatment responders and nonresponder s, respectively; 76% of treatment responders showed a greater than or equal to 50% decline in Hamilton depression scale score versus 14% of nonrespond ers. Quality of life was similarly improved in treatment responders. Conclusions: Sildenafil is efficacious for erectile dysfunction in men with mild-to-moderate depressive illness. improvement of erectile dysfunction i s associated with marked improvement in depressive symptoms and quality of life.