title: Sexual function during long-term duloxetine treatment in patients with recurrent major depressive disorder.
abstract: BACKGROUND
  Sexual dysfunction (SD) is frequently associated with major depressive disorder (MDD) in the untreated state and may be worsened by antidepressant treatment.
  
  
  OBJECTIVE
  We evaluated SD in duloxetine-treated patients during an MDD recurrence prevention study.
  
  
  METHODS
  Patients (N = 514) received open-label duloxetine 60-120 mg/day for up to 34 weeks. Responders (N = 288) were randomly assigned to duloxetine or placebo during a further 52-week double-blind maintenance phase.
  
  
  METHODS
  The Arizona Sexual Experience Scale (ASEX) was used to assess sexual functioning.
  
  
  RESULTS
  At study entry, 73.4% of patients met ASEX criteria for SD. After open-label duloxetine treatment, the probability of continued SD was 77.9% for nonresponders and 53.2% for responders. In patients without SD at study entry, the probability of emergent SD was 49.6% (nonresponders) and 33.2% (responders). In the double-blind maintenance phase, there was no significant difference (P = 0.105) in the probability of emergent SD between placebo-treated (49.2%) and duloxetine-treated (27.9%) patients without SD at baseline, with no significant treatment-by-gender interaction. In patients with a recurrence of MDD, the probability of emergent SD was similar between placebo- (71.3%) and duloxetine-treated (82.7%) patients. However, in patients with no recurrence of MDD, the probability of emergent SD in placebo patients (40.0%) was numerically higher than in duloxetine patients (12.9%). Spontaneous reports of adverse events related to sexual function were infrequent and no patients discontinued due to these events.
  
  
  CONCLUSIONS
  In patients with MDD, the probability of continued or emergent SD after up to 34 weeks of open-label duloxetine treatment was associated with the response status of the patients. In patients who responded to duloxetine treatment, after up to a further 52 weeks of double-blind treatment either with duloxetine or placebo, the probability of continued or emergent SD appeared to be more related to MDD itself than the treatments that the patients received.
authors.affiliation: Hospital Universitario de Salamanca, Salamanca, Spain.
authors.forename: Angel-Luis
authors.initials: AL
authors.lastname: Montejo
authors.forename: David G S
authors.initials: DG
authors.lastname: Perahia
authors.forename: Melissa E
authors.initials: ME
authors.lastname: Spann
authors.forename: Fujun
authors.initials: F
authors.lastname: Wang
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Walker
authors.forename: Charles R
authors.initials: CR
authors.lastname: Yang
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Detke
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D012725:Sexual Behavior / Q000187:drug effects / Q000523:psychology; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced*; D011795:Surveys and Questionnaires; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride