Background: Sexual dysfunction is a well-known side effect of many antidepressants. Obtaining accurate data on sexual dysfunction from clinical trials is difficult because of methodological problems. This paper reviews the assessment and reporting of sexual dysfunction in clinical trials.
Methods: 79 randomized double-blind studies comparing efficacy and tolerability of new antidepressants in major depressive disorder were included. Papers were searched for the methodology of adverse event assessment and for any information on treatment-emergent sexual dysfunction.
Results: 74.7% of the reviewed studies relied on spontaneous reports, 17.7% on non-specific side-effect checklists and only 7.6% on specific assessment instruments. 31.6% of the reviewed studies reported sexual dysfunction as a side effect of antidepressant treatment. Detailed information on the kind of sexual dysfunction based on DSM-IV terminology was provided by only 10.1% of the papers. More recent studies published in 2000 or later reported sexual dysfunction more often (48.6%) than studies published before the year 2000 (18.2%).
Discussion: The specific assessment of sexual dysfunction should be adopted as a part of the safety and tolerability assessment in clinical trials. Future research is needed to elaborate the advantages and disadvantages of the available instruments for the assessment of sexual dysfunction.