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.
"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. "
[Show abstract][Hide abstract] ABSTRACT: This study assessed the efficacy, tolerability and safety of vortioxetine versus placebo in adults with recurrent major depressive disorder. This double-blind, randomized, placebo-controlled study included 608 patients [Montgomery-Åsberg Depression Rating Scale (MADRS) total score≥26 and Clinical Global Impression - Severity score≥4]. Patients were randomly assigned (1 : 1 : 1 : 1) to vortioxetine 15 mg/day, vortioxetine 20 mg/day, duloxetine 60 mg/day or placebo. The primary efficacy endpoint was change from baseline in MADRS total score at week 8 (mixed model for repeated measurements). Key secondary endpoints were: MADRS responders; Clinical Global Impression - Improvement scale score; MADRS total score in patients with baseline Hamilton Anxiety Rating Scale ≥20; remission (MADRS≤10); and Sheehan Disability Scale total score at week 8. On the primary efficacy endpoint, both vortioxetine doses were statistically significantly superior to placebo, with a mean difference to placebo (n=158) of -5.5 (vortioxetine 15 mg, P<0.0001, n=149) and -7.1 MADRS points (vortioxetine 20 mg, P<0.0001, n=151). Duloxetine (n=146) separated from placebo, thus validating the study. In all key secondary analyses, both vortioxetine doses were statistically significantly superior to placebo. Vortioxetine treatment was well tolerated; common adverse events (incidence≥5%) were nausea, headache, diarrhea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters. Vortioxetine was efficacious and well tolerated in the treatment of patients with major depressive disorder.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.
International clinical psychopharmacology 11/2013; 29(3). DOI:10.1097/YIC.0000000000000018 · 2.46 Impact Factor
"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 "
"It remains unclear what effects trazadone has on sexual function; Rattya et al  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 . 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%). "
[Show abstract][Hide abstract] ABSTRACT: Numerous studies have now demonstrated that many older women retain an interest in their sexual lives. Yet, how many old age psychiatrists commonly check with older women about whether the depression they are treating, or the SSRIs (Selective Serotonin Re-uptake Inhibitors) they have prescribed, have adversely affected their patient's sexual lives? We consider the latest evidence regarding cultural, social and medical influences on older women's sexual lives and some specific issues which affect lesbian and transsexual people. We examine how mental illness and psychotropic medication in particular can adversely affect older women's sexual functioning and at how difficult it often proves to be for women to seek help. We also focus on why doctors and in particular psychiatrists may not take a sexual history, look for sexual side effects or refer for appropriate treatment, especially when interviewing older women patients. Most published information about psychiatric training and sexual issues focuses on the younger male patient. We therefore aimed to provide a broad-ranging review of the literature regarding female sexual functioning in old age, the difficulties that can arise and the role that old age psychiatrists have an opportunity to fulfil, in this often neglected aspect of their patients' treatment. From our review it was clear that, in the light of the increasing cultural acceptability of discussions regarding sexuality and older women, the training of student doctors and trainee psychiatrists needs to reflect this change so that old age psychiatrists can enhance the quality of their patient care.
Aging and Disease 10/2012; 3(5):373-84. · 3.07 Impact Factor
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