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Psych Congress  

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

Ken Kramer, PhD
Anita H. Clayton, MD
Suresh Durgam, MD
Changzheng Chen, PhD
Adam Ruth, PhD
Carl Gonmoll, MS
Forest Laboratories, LLC, an affiliate of Actavis, Inc

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

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