title: Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial.
abstract: Sexual dysfunction commonly occurs with major depressive disorder (MDD). Vilazodone, a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist antidepressant approved for the treatment of MDD in adults, was evaluated to determine its effects on sexual function. The primary study was a double-blind, randomized, controlled trial comparing vilazodone 20 and 40 mg/day with placebo; citalopram 40 mg/day was an active control (NCT01473381; http://www.clinicaltrials.gov). Post-hoc analyses evaluated change from baseline to week 10 on the Changes in Sexual Functioning Questionnaire (CSFQ); no inferential statistics were performed. CSFQ scores increased for women [1.2 (citalopram) to 3.0 (vilazodone 40 mg)] and men [1.2 (vilazodone 40 mg) to 3.5 (placebo)] in all treatment groups. Greater changes in CSFQ scores were seen in responders [women: 2.33 (citalopram) to 5.06 (vilazodone 40 mg); men: 2.26 (vilazodone 40 mg) to 4.35 (placebo)] versus nonresponders. CSFQ change from baseline was small for patients with normal baseline sexual function; in patients with baseline sexual dysfunction, CSFQ scores improved across groups [women: 2.35 (citalopram) to 4.52 (vilazodone 40 mg); men 2.83 (vilazodone 40 mg) to 6.43 (placebo)]. Across treatment groups, baseline sexual function improved in women and men, MDD responders, and patients with baseline sexual dysfunction.
authors.affiliation: aDepartment of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia bForest Research Institute, Jersey City, New Jersey, USA.
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
authors.forename: Carl
authors.initials: C
authors.lastname: Gommoll
authors.forename: Dalei
authors.initials: D
authors.lastname: Chen
authors.forename: Rene
authors.initials: R
authors.lastname: Nunez
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D054333:Drug Partial Agonism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D012307:Risk Factors; D058825:Serotonin 5-HT1 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012725:Sexual Behavior / Q000187:drug effects*; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis / Q000523:psychology*; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000523:psychology*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D000069503:Vilazodone Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D058825:Serotonin 5-HT1 Receptor Agonists; D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride