title: The effect of vilazodone on sexual function during the treatment of major depressive disorder.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, USA Department of Psychiatry, University Health Network, University of Toronto, ON, Canada Forest Laboratories, Inc., Jersey City, NJ, USA Clinical Data, Inc., Newton, MA, USA (acquired by Forest Laboratories, Inc.; now Dogwood Pharmaceuticals, Inc.).
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
authors.forename: Sidney H
authors.initials: SH
authors.lastname: Kennedy
authors.forename: John B
authors.initials: JB
authors.lastname: Edwards
authors.forename: Susan
authors.initials: S
authors.lastname: Gallipoli
authors.forename: Carol R
authors.initials: CR
authors.lastname: Reed
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D015995:Prevalence; D058825:Serotonin 5-HT1 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D012725:Sexual Behavior / Q000187:drug effects*; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D001572:Benzofurans; D007211:Indoles; D010879:Piperazines; D058825:Serotonin 5-HT1 Receptor Agonists; D000069503:Vilazodone Hydrochloride