A placebo controlled comparison of the antidepressant efficacy and effectson sexual functioning of sustained-release bupropion and sertraline

Sexual dysfunction, a frequently reported side effect of many antidepressan ts, may result in patient dissatisfaction and noncompliance with treatment regimens. This paper describes the results of the first placebo-controlled comparison of the efficacy, safety, and effects on sexual functioning of su stained-release bupropion (bupropion SR) and the selective serotonin reupta ke inhibitor sertraline. This randomized, double-masked, double-dummy, para llel-group, multicenter trial enrolled 360 patients with moderate-to-severe recurrent major depression. Patients were treated with bupropion SR 150 to 400 mg/d, sertraline 50 to 200 mg/d, or placebo for up to 8 weeks. Patient s' depression and sexual functioning were assessed at weekly or biweekly cl inic visits; safety was assessed by regular monitoring of adverse events, v ital signs, and body weight. Treatment groups were similar at baseline in t erms of age, sex, and race, and most patients had a diagnosis of moderate u ncomplicated depression. Patients treated with bupropion SR or sertraline s howed similar improvements on all efficacy measures; both active treatments were superior to placebo in improving scores on all rating scales for depr ession at various time points. Significantly more patients treated with ser traline experienced orgasmic dysfunction throughout the study than did pati ents treated with bupropion SR or placebo (P < 0.001). Headache was the mos t frequently reported adverse event in all 3 treatment groups and occurred with similar frequency in each group (30% to 40%). Nausea (31%), diarrhea ( 26%), insomnia (18%), and somnolence (17%) occurred in significantly more p atients in the sertraline group than in the bupropion SR group (18%, 7%, 13 %, and 3%, respectively) and the placebo group (10%, 11%, 4%, and 6%, respe ctively). Dry mouth occurred more frequently with bupropion SR (19%) than w ith sertraline (14%) or placebo (12%), although the differences were not si gnificant. Changes in vital signs were similar in all groups. Similar (smal l, but not statistically significant) decreases in mean body weight were se en in both the bupropion SR (-1.06 kg) and sertraline (-0.79 kg) groups, wh ereas the placebo group experienced a minor increase (0.21 kg). Although bu propion SR and sertraline were similarly well tolerated and effective in th e treatment of depression, sertraline treatment was more often associated w ith sexual dysfunction and certain other adverse events compared with bupro pion SR and placebo. Therefore, bupropion SR may be an appropriate choice a s an antidepressant for the treatment of sexually active patients.