Extended-Release Bupropion for Patients With Major Depressive Disorder Presenting With Symptoms of Reduced Energy, Pleasure, and Interest: Findings From a Randomized, Double-Blind, Placebo-Controlled Study
J Clin Psychiatry 2006;67(6):865-873
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: This multicenter, double-blind,
placebo-controlled study evaluated the efficacy
and safety of extended-release bupropion
(bupropion XL) in the treatment of major depressive
disorder (MDD) with prominent symptoms of
decreased energy, pleasure, and interest.
Method: Eligible adult outpatients
meeting DSM-IV criteria for MDD were randomly assigned to bupropion XL 300 to 450
mg/day (N = 135) or placebo (N = 139) for 8 weeks. The primary efficacy measure, change from
baseline on the 30-item Inventory of Depressive Symptomatology-Self Report (IDS-IVR-30) total
score, was obtained using interactive voice
response (IVR) technology. Secondary measures
included change from baseline on the 30-item Inventory
of Depressive Symptomatology-Clinician-Rated (IDS-C-30) total score and change in domain
subset scores for energy, pleasure, and interest;
for insomnia; and for anxiety. Response and remission rates were also calculated. Safety was
assessed by withdrawal rates, adverse events
(AEs), body weight, and vital signs. The study was
conducted from June 24, 2003, to June 30, 2004.
Results: Bupropion XL was superior to
placebo at endpoint in reducing the IDS-IVR-30
total score (p = .018) and the energy, pleasure, and
interest domain (p = .007) and the insomnia domain (p = .023) scores. IDS-C-30 outcomes were
also significant (p < .001; p < .001, and p = .008,
respectively). Clinician-rated remission rates were
significantly higher with bupropion XL than
placebo (32% vs. 18%, IDS-C-30; 41% vs. 27%, IDS-IVR-30), as were response rates (50% vs.
35%, IDS-C-30; 53% vs. 38%, Clinical Global Impressions-Improvement of Illness). Most AEs
were mild or moderate. The incidence of a > = 7%
body weight loss was 3.7% with bupropion XL and 1.4% with placebo.
Conclusion: Bupropion XL was effective
and well tolerated in MDD patients with decreased energy, pleasure, and interest.