Vardenafil in the Treatment of Erectile Dysfunction in Outpatients With Chronic Schizophrenia: A Flexible-Dose, Open-Label Study

Charalampos I. Mitsonis, M.D.; Panagiotis A. Mitropoulos, Ph.D.; Nikolaos P. Dimopoulos, M.D., M.Sc.; Evangelia G. Kararizou, M.D.; Vasiliki V. Psarra, M.D.; Fivos E. Tsakiris, M.D.; and Maria-Nefeli E. Katsanou, M.D.

Objective: The aim of this study was to evaluate the safety and efficacy of vardenafil in outpatients with chronic schizophrenia and erectile dysfunction and to investigate any effect on quality of life in this population.

Method: In this 12-week, open-label, flexible-dose study, 25 outpatients with chronic schizophrenia (DSM-IV criteria) and erectile dysfunction received vardenafil 10 mg as needed (at a maximum of 1 dose per day) with the option to maintain current dose or to titrate to 5 mg or 20 mg at 4 and 8 weeks. Assessment was performed with the International Index of Erectile Function (IIEF) at base line and at weeks 4, 8, and 12. The Quality of Life Scale (QLS) was administered at baseline and at week 12. The study was carried out at the Psychiatric Hospital of Athens, Greece, between October 2005 and November 2006.

Results: Vardenafil produced a statistically significant improvement in all IIEF domains [erectile function (p < .001), orgasmic function (p < .05), sexual desire (p < .05), intercourse satisfaction (p < .01), and overall satisfaction (p < .001)] and QLS (p < .003). Results were similar for the intention-to-treat (N = 25) and completer (N = 21, 84%) groups. Adverse events were infrequent and decreased in incidence over the course of the study.

Conclusion: Vardenafil was generally well tolerated and highly effective in outpatients with chronic schizophrenia and erectile dysfunction. The response to vardenafil was not influenced by certain patient characteristics, such as erectile dysfunction severity or serum prolactin levels. Improvement in sexual function was correlated with improvement in the quality of life.

(J Clin Psychiatry 2008;69:206-212; online ahead of print January 9, 2008)

Received March 24, 2007; accepted May 8, 2007. From the Psychiatric Hospital of Athens, Athens (Drs. Mitsonis, Dimopoulos, Psarra, Tsakiris, and Katsanou); the Department of Psychiatry (Dr. Mitsonis) and the Department of Neurology, Eginition Hospital (Dr. Kararizou), Athens University Medical School, Athens; and the Department of Business Administration, University of Patras, Patras (Dr. Mitropoulos), Greece.

This study was not supported by external funding.

The authors report no financial affiliations or other relationships relevant to the subject of this article.

Corresponding author and reprints: Charalampos I. Mitsonis, M.D., Psychiatric Hospital of Athens, Athens University Medical School, 7 Metamorfoseos St., GR- 15234 Halandri-Athens, Greece (e-mail: ectorcenter@yahoo.gr).