Symptoms of Sexual Dysfunction in Patients Treated for Major Depressive Disorder: A Meta-Analysis Comparing Selegiline Transdermal System and Placebo Using a Patient-Rated Scale

Anita H. Clayton, M.D.; Bryan J. Campbell, Pharm.D.; Antonella Favit, M.D., Ph.D.; Ying Yang, Ph.D.; George Moonsammy, Ph.D.; Catherine M. Piontek, M.D.; and Jay D. Amsterdam, M.D.

Objective: Spontaneous reports of sexual side effects were infrequent during placebo-controlled clinical trials of selegiline transdermal system (STS). The objective of this study was to examine the impact of STS 6 mg/24 hours on various domains of sexual function in patients with major depressive disorder (MDD), using a patient-rated questionnaire.

Method: Data from 4 short-term (6 to 8 weeks), randomized, double-blind, placebo-controlled trials of STS in patients with MDD (DSM-IV criteria) were included in the meta-analysis (STS, N = 389; placebo, N = 400). The Medex Sexual Dysfunction Subscale was used to assess sexual interest, arousal, maintenance of interest, orgasm, and satisfaction. Estimates of the average effect of study drug on each item of sexual function and 95% confidence intervals were calculated using a fixed-effects model due to homogeneity of study means. The direct effect of STS versus placebo was estimated using multivariate regression models, with baseline item score as a covariate and controlling for improvement in depression. Analyses were performed on the total population and by gender. Data were collected between January 1997 and April 2000.

Results: Estimates of difference between STS and placebo demonstrated a nonsignificant trend toward a positive treatment effect of STS on most sexual function items and significant improvement in sexual satisfaction. For women, there was a significant positive effect on interest, maintaining interest during sex, and satisfaction. The direct effect of STS on changes in individual item scores was minimal in men and showed a trend for improvement in women.

Conclusion: This meta-analysis suggests that short-term therapy with STS 6 mg/24 hours does not impair any aspect of sexual function in MDD patients as measured using a patient-rated questionnaire.

(J Clin Psychiatry 2007;68:1860-1866)

Received Feb. 23, 2007; accepted Sept. 16, 2007. From the Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Health System, Charlottesville (Dr. Clayton); Neuroscience Medical Strategy (Drs. Campbell and Favit) and Global Biometric Sciences (Dr. Yang), Bristol-Myers Squibb Co., Plainsboro, N.J.; Clinical and Regulatory Affairs, Somerset Pharmaceuticals, Inc., Tampa, Fla. (Dr. Moonsammy); Scientific Affairs, IneXel Medical Strategy & Communications, Lawrenceville, N.J. (Dr. Piontek); and the Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia (Dr. Amsterdam). Dr. Favit is currently with Shire Pharmaceuticals in Wayne, Pa., and Dr. Moonsammy is a consultant in Tampa, Fla.

The data in this article were derived from research studies sponsored and funded by Somerset Pharmaceuticals, Inc. Funding for assistance with manuscript editing by IneXel Medical Strategy & Communications was provided by Bristol-Myers Squibb.

Financial disclosure appears at the end of this article.

Corresponding author and reprints: Anita H. Clayton, M.D., Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Health System, P.O. Box 800623, Charlottesville, VA 22908 (e-mail: ahc8v@virginia.edu).