A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine

Background: Many antidepressants are associated with sexual dysfunction, a side effect that may lead to patients' dissatisfaction and noncompliance wi th treatment. Objective: This study compared the efficacy, tolerability, and effects on s exual functioning of bupropion sustained release (bupropion SR) and the sel ective serotonin reuptake inhibitor fluoxetine. Methods: In this multicenter, randomized, double-blind, double-dummy, paral lel-group study, patients with recurrent major depression were treated with bupropion SR 150 to 400 mg/d, fluoxetine 20 to 60 mg/d, or placebo for up to 8 weeks. Depression and sexual-functioning status were assessed by site- specific trained investigators at weekly clinic visits; tolerability was as sessed primarily by monitoring adverse events. Results: Four hundred fifty-six patients participated in the study, 150 rec eiving bupropion SR, 154 fluoxetine, and 152 placebo. The majority of patie nts in each group completed the study (63% each, bupropion SR [n = 94] and fluoxetine [n = 97]; 67%, placebo [n = 102]). Bupropion SR and fluoxetine w ere similarly effective in the treatment of depressive symptoms. Beginning at week 2 and continuing throughout the study, significantly more fluoxetin e-treated patients experienced orgasm dysfunction than did patients receivi ng bupropion SR or placebo (P < 0.001); similar results were seen in patien ts defined as clinical responders (greater than or equal to 50% decrease fr om baseline in 21-item Hamilton Rating Scale for Depression [HAM-D] total s core) (P < 0.001) and in those experiencing remission of depression (HAM-D total score <8) (P < 0.05). At various time points, worsened sexual functio ning, sexual desire disorder, sexual arousal disorder, and dissatisfaction with sexual functioning in those satisfied at baseline were more frequently associated with fluoxetine. treatment than with bupropion SR or placebo. B oth active treatments were well tolerated. Conclusions: Bupropion SR and fluoxetine were similarly effective and well tolerated in the treatment of depression. Fluoxetine, however, was more fre quently associated with sexual dysfunction compared with bupropion SR. Bupr opion SR may be an appropriate initial choice for the treatment of depressi on in patients concerned about sexual functioning.