RESUMEN
OBJECTIVE: To evaluate frequencies of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD) treated with duloxetine or selective serotonin reuptake inhibitor (SSRI) monotherapy for up to 6 months in a prospective, observational study. METHODS: Sexually active MDD patients without sexual dysfunction at entry were enrolled from twelve countries (N = 1,647). TESD was assessed over the study period using the Arizona sexual experience (ASEX) scale. A priori-specified secondary 6-month clinical endpoints were also examined. RESULTS: The frequency of TESD at 6 months with duloxetine was comparable to that with SSRI monotherapy (23.4 and 28.7%, respectively; P = 0.087). Improvements in Clinical Global Impressions of Severity (CGI-S), 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR(16)), Integral Inventory for Depression (IID) total scores, remission and sustained remission rates were statistically significantly greater with duloxetine than SSRI monotherapy at 6 months (P < 0.001 for each), but TESD attenuated improvements in quality of life measures. Four factors were consistently significantly (P ≤ 0.05) associated with TESD at week 8 and 6 months. CONCLUSIONS: Six-month TESD rates were comparable between duloxetine and SSRIs, with greater MDD effectiveness in favour of duloxetine. Improved recognition and management of TESD may improve quality of life for MDD patients in usual clinical practice.
