Safety profile of sustained-release bupropion in depression: Results of three clinical trials

This series of studies was undertaken to assess the safety profile of susta ined-release (SR) bupropion in the treatment of depressed outpatients. Adul ts with a diagnosis of major depression were evaluated in 1 of 3 multicente r, randomized, double-masked, parallel-group, placebo-controlled trials con ducted in private-practice psychiatric outpatient clinics. Following a 1-we ek, single-masked, placebo lead-in period, patients received bupropion SR f or 8 weeks (study 1: 150 or 300 mg/d; study 2: 100, 200, 300, or 400 mg/d; study 3: 50 to 150 or 100 to 300 mg/d). Safety assessments included monitor ing adverse events, patient discontinuation rates, changes in weight, vital signs, and clinical laboratory test results. Across studies, the most freq uently reported adverse events were headache, dry mouth, and nausea. The in cidence of adverse events was similar (less than or equal to 5% difference) between the bupropion SR and placebo groups, with the exception of dry mou th (bupropion SR, 16%; placebo, 7%). Dry mouth, nausea, and insomnia occurr ed significantly more often in bupropion SR-treated patients than in patien ts who received placebo (P < 0.05). Nearly all (94% to 99%) adverse events reported in these studies were mild or moderate. Less than 10% of patients in either group discontinued treatment prematurely because of adverse event s, and no deaths or serious drug-related adverse events were reported. Sexu al dysfunction was reported as an adverse event by <1% of patients in eithe r group. Bupropion SR was associated with dose-related weight loss in all 3 studies. No consistent patterns of change were observed in vital signs or in the results of clinical laboratory tests. Data from these 3 clinical tri als demonstrate the favorable safety profile of bupropion SR in the treatme nt of depressed outpatients.