A MULTICENTER EVALUATION OF THE EFFICACY AND SAFETY OF 150 AND 300 MGD SUSTAINED-RELEASE BUPROPION TABLETS VERSUS PLACEBO IN DEPRESSED OUTPATIENTS/

This multicenter, randomized, double-masked, placebo-controlled, paral lel-group study compared the antidepressant efficacy and safety of bup ropion sustained-release (SR) tablets (150 mg QD or 150 mg BID) with p lacebo in outpatients with moderate-to-severe depression. The study co nsisted of a 1-week placebo phase followed by 8 weeks of active treatm ent with bupropion SR 150 mg/d (150 mg QD, n = 121) or 300 mg/d (150 m g BID, n = 120) or placebo (n = 121). Efficacy was measured by changes in scores on the 17-item Hamilton Rating Scale for Depression (HAM-D) and the Clinical Global Impressions for Severity of Illness (CGI-S) a nd Clinical Global Impressions for Improvement of Illness (CGI-I) scal es. Safety was monitored by regular assessment of vital signs and adve rse events as well as by pretreatment and posttreatment physical and c linical laboratory examinations. By day 56, both bupropion SR treatmen ts were more effective in relieving the symptoms of depression than wa s placebo. Compared with those receiving placebo, patients in the bupr opion SR 150- and 300-mg/d groups had significantly reduced symptoms b y treatment day 56, as measured on the 17-item HAM-D, CGI-S, and CGI-I scales (P < 0.05). Bupropion SR was well tolerated, with no serious a dverse events reported by bupropion-treated patients; 95% of all repor ted adverse events were of mild or moderate intensity. No clinically s ignificant changes in vital signs, laboratory test results, or physica l findings were observed. A greater mean weight loss was observed at t he end of treatment in both the bupropion SR 150-mg (0.5 kg) and bupro pion SR 300-mg (1.0 kg) group compared with placebo (0.2 kg). We found that bupropion SR 150 mg administered either once or twice daily was more effective than placebo in treating depression and that once-daily dosing appears to be at least as effective as twice-daily dosing. Sho uld this prove true, depressed patients may be able to benefit from th e convenience and improved tolerability associated with once-daily dos ing.