title: The effect of gepirone-ER in the treatment of sexual dysfunction in depressed men.
abstract: BACKGROUND
  Sexual dysfunction is common in patients with major depressive disorder (MDD). Antidepressant medications especially the selective serotonin reuptake inhibitors (SSRIs) may improve depressive symptoms but further decrease sexual function. Gepirone extended release (gepirone-ER) differs from the SSRIs in only affecting the 5-HT(1A) receptor and has demonstrated efficacy in treatment of depression and sexual dysfunction in depressed women. This report describes the effect of gepirone-ER on sexual function in depressed men.
  
  
  OBJECTIVE
  The aims of this article were to study the effects of gepirone-ER on sexual function in men with MDD and to determine if positive effects are independent of antidepressant or anxiolytic activity.
  
  
  METHODS
  The main outcome measures of this article were Hamilton depression rating scale (HAMD-17), and changes in sexual functioning questionnaire (CSFQ).
  
  
  METHODS
  In an 8-week study, gepirone-ER, placebo, or fluoxetine were administered in a double-blind fashion to 181 depressed men. The CSFQ results were used to determine quality of sexual function. To test for an antidepressant or anxiolytic effect, a 50% reduction in HAMD-17 score separated antidepressant responders from nonresponders, and item 12 of the HAMD scale (psychic anxiety) scores of 0 or 1 separated anxiolytic responders from nonresponders.
  
  
  RESULTS
  Gepirone-ER treatment improved total sexual function compared with placebo measured by the CSFQ at weeks 4 (P=0.012) and 8 (P=0.046). At 4 weeks, almost every CSFQ domain is improved. The orgasm domain was especially improved, 67% by week 4. Gepirone-ER antidepressant and anxiolytic nonresponders showed significant improvement in sexual function. Fluoxetine treatment did not produce improvement. In fact, fluoxetine-treated subjects had lower scores on the total CSFQ, less than placebo, and significantly less than gepirone-ER.
  
  
  CONCLUSIONS
  Gepirone-ER improves sexual dysfunction in depressed men. All domains of sexual function improved. Gepirone-ER has a pro-sexual effect independent of antidepressant or anxiolytic activity.
authors.affiliation: Fabre-Kramer Pharmaceuticals, Houston, TX 77057, USA. lfabre@fabrekramer.com
authors.forename: Louis F
authors.initials: LF
authors.lastname: Fabre
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
authors.forename: Louis C
authors.initials: LC
authors.lastname: Smith
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Derogatis
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000150:complications / Q000188:drug therapy*; D020018:Sexual Dysfunctions, Psychological / Q000150:complications / Q000188:drug therapy*
chemical_list: D000928:Antidepressive Agents; D003692:Delayed-Action Preparations; D011743:Pyrimidines; C039979:gepirone