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An Open-Label Pilot Study to Evaluate the Efficacy of Sildenafil Citrate in Middle-Aged Men With Late-Onset Dysthymia

Orr, Guy MD*†; Seidman, Stuart N. MD‡§; Weiser, Mark MD*†; Gershon, Ari A. MD; Dubrov, Yael BA*†; Klein, Donald F. MD‡§

The Journal of Nervous and Mental Disease: June 2008 - Volume 196 - Issue 6 - p 496-500
doi: 10.1097/NMD.0b013e3181773913
Brief Report

Late onset dysthymic disorder (DD) in middle-aged and elderly men responds poorly to established antidepressants. Previous studies noted an improvement in mood accompanying sildenafil citrate treatment for erectile dysfunction. We sought to evaluate whether sildenafil’s mood effects were independent of the effect on erectile function. A 6-week open label study was conducted with 20 male participants, aged 41–60 who were diagnosed with DD and who had normal erectile function. Participants were treated with sildenafil citrate 25 mg per day for 6 weeks. The primary outcome measure was the 21-item Hamilton Depression Rating Scale. Depressive and sexual symptoms were also evaluated using self-report questionnaires. Treatment with sildenafil resulted in a significant reduction in Hamilton Depression Rating Scale mean scores: from 14.61 ± 3.5 at baseline to 6.39 ± 5.13 at end of study (F(3,51) = 32.52, p ≤ 0.001). No changes in sexual functioning were detected. Significant improvement was also noted on the self-report measures of depressive symptoms. Sildenafil citrate might have an antidepressant effect on late onset DD, that is not attributable to improvement in erectile function. Possible explanations for this effect are offered. Larger placebo controlled studies are warranted.

*Department of Psychiatry Sheba Medical Center, Tel-Hashomer, Israel; †Department of Psychiatry, Israel; ‡New York State Psychiatric Institute; §Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York; and ∥Institute for Functional Assessment, Sheba Medical Center, Tel-Hashomer, Israel.

An investigator initiated independent grant of $47,760 plus medication from Pfizer Inc. New York—Pfizer Inc. 235 East 42nd Street, New York, NY (to G.O., S.N.S.).

Send reprint requests to Guy Orr, MD, Department of Psychiatry, Sheba Medical Center, Tel-Hashomer 52621, Israel. E-mail:

© 2008 Lippincott Williams & Wilkins, Inc.