A group of US Food and Drug Administration scientists held a forum to discuss how to better evaluate side effects of sexual dysfunction associated with antidepressant drugs during clinical trials, and published their report in the Journal of Clinical Psychiatry.
“Sexual dysfunction is an important side effect of serotonergic antidepressants,” they wrote. “However, sexual dysfunction is often underestimated in clinical trials submitted in support of drug approval. This is because such assessments are based mainly on unsolicited reporting.”
The authors reported on the FDA’s current efforts to develop methodologies for more accurately capturing the scope and severity of sexual dysfunction side effects occurring in trials of new antidepressants.
Khin, Ni A., Phillip D. Kronstein, Peiling Yang, Eiji Ishida, H. M. James Hung, Mitchell V. Mathis, Ellis F. Unger, and Robert J. Temple. “Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials.” The Journal of Clinical Psychiatry, June 7, 2015. doi:10.4088/JCP.14cs09700. (Abstract)