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A multicenter, double-blind, placebo-controlled study of sildenafil citrate in Canadian men with erectile dysfunction and untreated symptoms of depression, in the absence of major depressive disorder

Kennedy, Sidney H.a; Dugré, Hélèneb; Defoy, Isabellec

International Clinical Psychopharmacology: May 2011 - Volume 26 - Issue 3 - p 151–158
doi: 10.1097/YIC.0b013e32834309fc
Original Articles

Depression and erectile dysfunction (ED) often co-occur. Phosphodiesterase type 5 inhibitors are effective in men with ED and untreated depression, or ED secondary to antidepressants. This study evaluated sildenafil treatment in Canadian men with clinically diagnosed ED (Sexual Health Inventory for Men score ≤21) and mild-to-moderate untreated depressive symptoms [Beck Depression Inventory II (BDI-II) score 14–28], but excluding major depressive disorder. Pretreatment screening using the Sexual Health Inventory for Men and BDI-II showed that men with ED were more likely to have depression than men without ED, and ED severity was a predictor of depression (P=0.0226). Two hundred and two men were randomized to 6 weeks of double-blind treatment with placebo (n=98) or sildenafil (n=104), initial dose of 50 mg, adjustable to 25 or 100 mg. The men were evaluated on all domains of the International Index of Erectile Function and the Sex Effects Questionnaire, Global Efficacy Questions, and Event-log data. Compared with placebo, patients treated with sildenafil had significantly greater changes from baseline in BDI-II scores (P<0.001). All International Index of Erectile Function domains and the Sex Effects Questionnaire components were also significantly improved in sildenafil group (P<0.01). The most common adverse events included headache, dyspepsia, vasodilatation, and respiratory tract infections and were generally mild in intensity.

aUniversity Health Network, University of Toronto, Toronto, Ontario

bCentre Hospitalier de l'Université de Montréal-Hôpital St-Luc, Montréal

cPfizer Canada Inc., Kirkland, Quebec, Canada

Correspondence to Dr Sidney H. Kennedy, MD, FRCPC, University Health Network, University of Toronto, 200 Elizabeth Street, Eaton North, 8th Floor, Room 222, Toronto, ON M5G 2C4, Canada Tel: +1 416 340 3888; fax: +1 416 340 4198; e-mail:

Received July 30, 2010

Accepted November 24, 2010

© 2011 Lippincott Williams & Wilkins, Inc.