title: Effects of vilazodone on sexual functioning in healthy adults: results from a randomized, double-blind, placebo-controlled, and active-controlled study.
abstract: The aim of this study is to evaluate the effects of vilazodone on sexual functioning in healthy, sexually active adults and assess the impact of medication nonadherence in this type of trial. Participants were randomized to vilazodone (20 or 40 mg/day), paroxetine (20 mg/day), or placebo for 5 weeks of double-blind treatment. The primary endpoint was change from baseline to day 35 in Change in Sexual Functioning Questionnaire (CSFQ) total score in the intent-to-treat (ITT) population. Post-hoc analyses were carried out in modified intent-to-treat (mITT) populations that excluded participants in the active-treatment groups with undetectable plasma drug concentrations at all visits (mITT-I) or at least one visit (mITT-II). In the ITT population (N=199), there were no statistically significant differences between any treatment groups for CSFQ total score change: placebo, -1.0; vilazodone 20 mg/day, -1.4; vilazodone 40 mg/day, -1.9; and paroxetine, -3.5. In mITT-I (N=197) and mITT-II (N=159), CSFQ total score change was not significantly different between vilazodone (either dose) versus placebo; the CSFQ total score decreased significantly (P<0.05) with paroxetine versus both placebo and vilazodone 20 mg/day, but not versus vilazodone 40 mg/day. Vilazodone exerted no significant effect on sexual functioning in healthy adults. Medication nonadherence can alter study results and may be an important consideration in trials with volunteer participants.
authors.affiliation: aDepartment of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville bIndivior PLC, Richmond, Virginia cAllergan, Inc., Jersey City dThe Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, New Jersey, USA.
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
authors.forename: Suresh
authors.initials: S
authors.lastname: Durgam
authors.forename: Dayong
authors.initials: D
authors.lastname: Li
authors.forename: Changzheng
authors.initials: C
authors.lastname: Chen
authors.forename: Laishun
authors.initials: L
authors.lastname: Chen
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
authors.forename: Carl P
authors.initials: CP
authors.lastname: Gommoll
authors.forename: Armin
authors.initials: A
authors.lastname: Szegedi
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D017374:Paroxetine / Q000494:pharmacology; D017367:Selective Serotonin Reuptake Inhibitors / Q000494:pharmacology*; D012725:Sexual Behavior / Q000187:drug effects* / Q000502:physiology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride / Q000494:pharmacology*
chemical_list: D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride