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Title: Sustained-Release Bupropion Associated With Prevention of Depression Relapse: Presented at ECNP

"Sustained-Release Bupropion Associated With Prevention of Depression Relapse: Presented at ECNP"

By Paula Moyer PRAGUE, CZECH REPUBLIC -- October 13, 2003 -- Patients treated with sustained-release bupropion (Wellbutrin SR) for depression on a long-term basis are less likely to experience remission than patients who receive a placebo, according to findings presented here on September 22nd at the 16th Congress of the European College of Neuropsychopharmacology. "The sustained-release formulation of bupropion was effective at preventing relapse and well tolerated," said Karen Weihs, MD, staff psychiatrist, George Washington University Medical School, Washington, DC, United States. Dr. Weihs noted that she and her co-investigators documented a low rate of discontinuation, no changes in vital signs or laboratory values, and no weight gain for the yearlong study period. In this randomised, fixed-dose, double-blind, placebo-controlled study, the investigators wanted to determine the ability of bupropion SR to prevent relapse or recurrence in patients with depression compared to placebo. The 423 participants were patients with moderate to severe recurrent depression, who were known to have responded to bupropion SR, as measured by time to relapse and recurrence of depression. The investigators involved 22 outpatient centres in the study. After a 1-week screen phase, eligible subjects were enrolled in an 8-week open-label phase in which they were treated with 300 mg of bupropion SR daily. Subjects were defined as responders if they had a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2 at each of their last 3 visits. Responders then entered a 44-week double-blind phase. In this phase, patients were randomised to either 300 mg of bupropion SR daily or to placebo. Equal numbers of patients were randomised to each group. The team found bupropion SR to be effective in preventing either relapse or recurrence of depression for the duration of the treatment period, Dr. Weihs stated. When the investigators used Wilcoxon and log-rank tests, they found a statistically significant difference in favour of bupropion SR. During the double-blind phase, the median time to relapse or recurrence was 24 weeks for the placebo group compared with 44 weeks for the treatment group (P=0.004). The investigators also found that patients in the treatment arm tolerated bupropion SR well. The discontinuation rate was 9% in the open-label phase. During the double-blind phase, the placebo group had a discontinuation rate of less than 1%, while the treatment arm had a discontinuation rate of 4%. At the end of the open-label period, patients lost an average of 1.4 kg. During the double-blind phase, the treatment group lost an average of 1.2 kg, while the placebo group had an average weight gain of 0.02 kg. These differences in discontinuation and weight change were not significant, the authors stated. This study was funded by GlaxoSmithKline, manufacturers of Wellbutrin. [Study title: Long-Term Treatment With Bupropion SR Effectively Prevents The Relapse And Recurrence Of Depression. Abstract P1-197]

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