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Bupropion SR vs. Placebo for Weight Loss in Obese Patients with Depressive Symptoms
Authors:Adesh K. Jain M.D.  Roy A. Kaplan  Kishore M. Gadde  Thomas A. Wadden  David B. Allison  Edwin R. Brewer  Robert A. Leadbetter  Nathalie Richard  Barbara Haight  Brenda D. Jamerson  Kathleen S. Buaron  Alan Metz
Affiliation:1. East Bay Clinical Trial Center, Concord, California;2. Duke University Medical Center, Durham, North Carolina;3. University of Pennsylvania, Philadelphia, Pennsylvania;4. University of Alabama at Birmingham, Birmingham, Alabama;5. GlaxoSmithKline, Research Triangle Park, North Carolina
Abstract:Objective: This randomized, double-blind, placebocontrolled study evaluated the efficacy and tolerability of bupropion sustained-release (bupropion SR) in reducing weight and depressive symptoms in obese adults. Research Methods and Procedures: Obese adults (body mass index, 30 to 44 kg/m2) not currently meeting criteria for major depression but with depressive symptoms (Beck Depression Inventory score 10–30) received bupropion SR 300 mg/d or placebo for 26 weeks with a 500 kcal/d-deficit diet. Patients who lost <5% of baseline weight at week 12 had bupropion SR dosage or placebo increased to 400 mg/d in a blinded fashion. Results: The bupropion SR group (n = 193) lost an average of 4.4 kg (4.6% of baseline weight) vs. 1.7 kg (1.8% of baseline weight) on placebo (n = 191, p < 0.001, last-observation-carried-forward analysis). More patients in the bupropion SR group than in the placebo group (40% vs. 16% of intent-to-treat sample, 50% vs. 28% of completers, respectively) lost at least 5% of baseline weight (p < 0.05 at week 4, p < 0.001 at weeks 6 to 26). The percentage of patients reporting ≥50% decrease in depressive symptoms did not differ between groups, but depressive symptoms improved more with bupropion SR than with placebo among patients with a history of major depression (p < 0.05, weeks 4 to 26). In the sample as a whole, improvement in depressive symptoms was related to weight loss of ≥5% regardless of treatment (p < 0.0001). Bupropion SR was well-tolerated. Discussion: Bupropion SR in combination with a 500 kcal/d-deficit diet facilitated weight loss. Weight loss of ≥5% may improve mood in obese patients with depressive symptoms.
Keywords:bupropion sustained-release  antidepressant  anorexigens  depression  clinical trial
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