The Effect of Vilazodone on Sexual Function During the Treatment of Major Depressive Disorder

Abstract

Introduction Sexual dysfunction is common in major depressive disorder (MDD), and many serotonergic antidepressants adversely affect sexual function. Vilazodone, a novel serotonin (5-HT) reuptake inhibitor and 5-HT1A partial agonist approved for MDD, exerts its effects at the 5-HT transporter and at both presynaptic and postsynaptic 5-HT1A receptors. This mechanism may limit sexual dysfunction. Aim To summarize effects of vilazodone (40 mg/day, with food) on sexual function in adults with MDD. Methods Data sources were three Phase III studies: two 8-week, placebo-controlled studies (NCT00285376 and NCT00683592) and a 52-week open-label study (NCT00644358). Sexual function was assessed by analyzing changes from baseline to end of treatment (EOT) using validated measures. Main Outcome Measure Arizona Sexual Experience Scale or Changes in Sexual Functioning Questionnaire. Results Population included 869 patients (vilazodone, 436; placebo, 433) from placebo-controlled studies and 599 patients from the open-label study. Sexual dysfunction prevalence was high (50%, men; 68%, women) before treatment and declined during treatment in vilazodone and placebo groups, indicating improvement on average. At EOT, stable/improved sexual function was observed in ≥91% of patients in placebo-controlled studies; treatment group differences in sexual dysfunction at EOT were not statistically significant for either sex. Differences vs. placebo in changes from baseline of sexual function scores were small and were generally not statistically significant; effect sizes (Cohen's D) were generally of low magnitude. In the placebo-controlled studies, 8.0% of vilazodone-treated patients and 0.9% of placebo-treated patients reported ≥1 sexual-function-related treatment-emergent adverse event (P < 0.001). Conclusion Half of men and two thirds of women with MDD had sexual dysfunction at baseline; sexual function improved on average in both vilazodone and placebo groups. Results suggest that vilazodone may have a small adverse impact on sexual function in adults with MDD relative to the high prevalence of sexual dysfunction at baseline.

Efficacy and Safety of Vilazodone in Major Depressive Disorder

“…However, in a long-term 52-week open-label study of vilazodone, reports of sexual dysfunction treatment-emergent adverse events were similar to the 2 phase III 8-week trials. 30 Gastrointestinal adverse event incidence in the current study is consistent with observations from the vilazodone registration studies and a 52-week open-label safety study [10][11][12] ; as such, they were not unexpected here. Similar to prior studies, most instances of vilazodone-related diarrhea and nausea were mild or moderate in intensity, led to few premature discontinuations, occurred in the first few weeks of treatment, and were transient in nature.…”

“…Results of previous vilazodone studies that used prospective sexual dysfunction measures have shown that sexual functioning was similar for vilazodone-and placebo-treated patients in spite of prominent baseline sexual dysfunction. [10][11][12]30 Additionally, an 8-week trial may be too short of a time period to accurately assess sexual dysfunction. However, in a long-term 52-week open-label study of vilazodone, reports of sexual dysfunction treatment-emergent adverse events were similar to the 2 phase III 8-week trials.…”

Sexual Function Across Aging

“…Consideration may be given to use of bupropion or buspirone as adjunctive agents for antidepressantinduced sexual dysfunction or as primary pharmacotherapy for anxiety or depression, if appropriate, to help minimize or avoid development of sexual dysfunction. Vortioxetine [34] and vilazodone [35,36] are newer antidepressants that appear to have a lower incidence of sexual dysfunction associated with use and should be considered in treating patients with depression and anxiety who have experienced sexual dysfunction with other antidepressant medications.…”

The impact of severe mental disorders and psychotropic medications on sexual health and its implications for clinical management

“…Vilazodone appears to have a low incidence of spontaneously reported adverse effects on sexual function, which may be related to partial agonist effects at the 5-HT1A receptor: it does not differ from placebo in improvement of sexual function during acute treatment of major depressive episodes, and the "number needed to harm" for sexual adverse effects has been estimated as 7 in men and 23 in women [79][80][81] . Treatment with the novel "multimodal" antidepressant vortioxetine is associated with a low incidence of reported adverse effects on sexual function in men (3-5%) and women (1-2%), which may relate to its antagonist effects at the 5-HT3 receptor, and to indirect effects in increasing the availability of dopamine and noradrenaline 82 .…”