Reemergence of sexual dysfunction in patients with major depressive disorder: Double-blind comparison of nefazodone and sertraline

Background: Several different classes of antidepressants have been associat ed with sexual adverse effects. This double-blind, randomized trial compare d the effects of nefazodone and sertraline on reemergence of sexual dysfunc tion in depressed patients who had experienced sexual dysfunction as a resu lt of sertraline treatment. Depressive symptoms were also monitored. Method: One hundred five patients with DSM-III-R major depressive episode w ho were experiencing sexual dysfunction attributable to sertraline (100 mg/ day) were screened for entry. Eligible patients entered a 1-week washout pe riod that was followed by a 7- to 10-day single-blind placebo phase. Patien ts without symptoms of sexual dysfunction at the end of the single-blind pl acebo phase were randomly assigned to receive double-blind treatment with e ither nefazodone (400 mg/day) or sertraline (100 mg/day) for 8 weeks. Results: Nearly 3 times more sertraline-treated patients (76%; 25/33) exper ienced reemergence of sexual dysfunction (ejaculatory and/or orgasmic diffi culty) than did nefazodone-treated patients (26%; 10/39) (p < .001). In add ition, patients treated with nefazodone were more satisfied with their sexu al functioning than were patients treated with sertraline. Both treatment g roups demonstrated a similar and sustained improvement in depressive sympto ms. Both drugs were well tolerated, and the overall incidence of adverse re actions was similar for both treatment groups; however, 9 sertraline-treate d patients (26%) discontinued because of adverse events compared with 5 nef azodone-treated patients (12%). Of the patients discontinuing therapy for a dverse events, 5 of the sertraline-treated patients did so because of sexua l dysfunction reported as an adverse event, whereas only 1 of the nefazodon e-treated patients discontinued therapy secondary to sexual dysfunction. Conclusion: In this sample of patients with major depression who had recove red from sexual dysfunction induced by treatment with sertraline, nefazodon e treatment resulted in significantly less reemergence of sexual dysfunctio n than did renewed treatment with sertraline and provided continued antidep ressant activity.