Sexual Functioning Assessed in 4 Double-Blind Placebo- and Paroxetine-Controlled Trials of Duloxetine for Major Depressive Disorder
J Clin Psychiatry 2005;66(6):686-692
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: The onset or worsening of sexual
dysfunction is a common treatment-emergent side effect of
antidepressant medications. Post hoc analyses of pooled data from
placebo-controlled studies were utilized to assess sexual
functioning in patients receiving duloxetine or paroxetine.
Method: Acute-phase data were obtained from four
8-week, double-blind, placebo- and paroxetine-controlled trials
of similar design in which patients meeting DSM-IV criteria for
major depressive disorder were randomly assigned to receive
placebo (N = 371), duloxetine (40-120 mg/day; N = 736), or paroxetine
(20 mg/day; N = 359). Pooling of data from these studies was
anticipated during study design. This represented all available
data from duloxetine studies in which the Arizona Sexual
Experience Scale (ASEX) was administered both at baseline and
endpoint. Long-term data were available from extension phases in
2 of these trials in which acute treatment responders received
placebo (N = 129), duloxetine (80-120 mg/day; N = 297), or paroxetine
(20 mg/day; N = 140) for an additional 26 weeks. Data were
collected between March 2000 and July 2002.
Results: The incidence of acute
treatment-emergent sexual dysfunction was significantly lower
among duloxetine-treated patients compared with those receiving
paroxetine (p = .015), although both rates were significantly
higher than placebo ( p= .007 and p < .001 for duloxetine and
paroxetine, respectively). Treatment group differences in the
incidence of treatment-emergent dysfunction did not vary
significantly by gender. In female patients, acute
treatment-emergent sexual dysfunction was significantly lower in
the duloxetine treatment group compared with the paroxetine
treatment group (p = .032), with both rates being significantly
higher than placebo (p = .049 and p < .001 for duloxetine and
paroxetine, respectively). In the somewhat smaller group of male
patients, acute treatment-emergent dysfunction did not differ
significantly between duloxetine and placebo treatment groups,
but the incidence was significantly higher in paroxetine-treated
male patients compared with male placebo patients (p = .012). The
long-term incidence of treatment-emergent dysfunction did not
differ significantly between duloxetine-, paroxetine-, and
Conclusion: In this analysis of pooled data,
patients receiving duloxetine (40-120 mg/day) or paroxetine (20
mg/day) had a significantly higher incidence of acute
treatment-emergent sexual dysfunction when compared with placebo
patients. However, the incidence of acute treatment-emergent
dysfunction for duloxetine was significantly lower than that
observed for paroxetine.