Effects of Vilazodone on Sexual Function in Patients With Generalized Anxiety Disorder: A Pooled Analysis of 3 Randomized Controlled Trials

Introduction: Generalized anxiety disorder (GAD) may be associated with reduced sexual function. Vilazodone is an SSRI and 5-HT1A receptor partial agonist approved for major depressive disorder in adults. Vilazodone was evaluated in 3 positive double-blind, placebo-controlled trials in GAD; post hoc analyses of these pooled data assessed vilazodone's effect on sexual function in patients with GAD. Methods: One fixed-dose (NCT01629966) and 2 flexible-dose studies (NCT01766401, NCT01844115) were pooled; 20-mg/d and 40-mg/d vilazodone doses were combined for analyses. Sexual functioning was assessed by the Changes in Sexual Functioning Questionnaire (CSFQ) in the CSFQ analysis population (patients with CSFQ baseline and ≥1 postbaseline assessment). Analyses included mean change in CSFQ total score from baseline to end of treatment (EOT) and percentage of patients with sexual dysfunction (CSFQ score ≤47 [men] or ≤41 [women]) at EOT. Statistics were descriptive. Results: The pooled CSFQ analyses population comprised 577 placebo patients and 796 vilazodone patients. Mean CSFQ baseline scores for men: 50.1 (placebo) and 49.0 (vilazodone); for women: 42.2 (placebo) and 41.7 (vilazodone). Baseline sexual dysfunction in men: 36% (placebo) and 40% (vilazodone); in women: 47% (placebo) and 49% (vilazodone). Mean CSFQ score change from baseline to EOT in men (indicating improvement): +1.7 (placebo) and +0.9 (vilazodone); in women: +1.2 (placebo) and +1.4 (vilazodone). Improvement from baseline sexual dysfunction to normal sexual function at EOT for men: 40.6% (placebo) and 35.7% (vilazodone); for women: 24.9% (placebo) and 34.9% (vilazodone). Conclusions: In patients with GAD, vilazodone and placebo were associated with mean improvements in sexual function