Sexual Functioning Assessed in 4 Double-Blind Placebo- and Paroxetine-Controlled Trials of Duloxetine for Major Depressive Disorder

Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio, USA.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 07/2005; 66(6):686-92. DOI: 10.4088/JCP.v66n0603
Source: PubMed


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.
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.
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 placebo-treated patients.
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.

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    • "The main analysis of the ASEX data was performed to assess the number of participants who were normal at baseline but developed sexual dysfunction during the study period. Sexual dysfunction was defined as an ASEX total score of at least 19, a score of at least 5 on any item or a score of at least 4 on any three items (Delgado et al., 2005). Analysis of ASEX data was performed by logistic regression using a model that included treatment, baseline sexual dysfunction status, baseline sexual dysfunction status by treatment interaction and baseline score. "
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    • "g - nificantly different from that of fluoxetine or paroxetine . Drug - placebo differences in mean changes in electrocardiograms ( eg , QTc , PR , and QRS intervals ) were neither statistically nor clinically significant , with the exception of duloxetine 120 mg / day , which significantly decreased PR and QRS intervals com - pared with placebo . Delgado et al . ( 2005 ) found the incidence of acute treatment - emergent sexual dysfunction is higher with duloxetine com - pared with placebo , but is significantly lower when compared with paroxetine . However , Dueñas et al . ( 2011 ) found treat - ment - emergent sexual dysfunction in duloxetine and SSRI monotherapy to be comparable ( 23 . 4% versus 28 "
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    • "It remains unclear what effects trazadone has on sexual function; Rattya et al [50] reported increased libido. Duloxetine's effect on sexual function was assessed in 4 randomised double blind placebo and paroxetine controlled trials in patients with major depression in a study by Delgarno et al [51]. It was found to have a higher rate of treatment-emergent sexual dysfunction (46.4%) than placebo (28.8%) but significantly lower rate than paroxetine (64.1%). "
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