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Eight-week, placebo-controlled, double-blind comparison of the antidepressant
efficacy and tolerability of bupropion XR and venlafaxine XR
K Hewett1*,
W Chrzanowski2,
M Schmitz3,
A Savela4,
V Milanova5,
M Gee1,
A Krishen6,
L Millen1,
M O Leary7,
and
J Modell6
1 GlaxoSmithKline, New Frontier Science Park, Harlow, UK
2 Psychiatric Clinic, Academy of Medicine, Choroszcz,
Poland
3 Department of Psychiatry, Psychosomatic Institute, Vienna,
Austria
4 Department of Psychiatry, Klaara-Keskus, Helskinki,
Finland
5 Department of Psychiatry, Alexander University Hospital, Sofia,
Bulgaria
6 GlaxoSmithKline, Research Triangle Park, NC, USA
7 GlaxoSmithKline, Greenford, UK
* To whom correspondence should be addressed.
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Abstract |
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Abstract
The efficacy, safety and tolerability of bupropion XR and venlafaxine XR was assessed
and compared with placebo in adult outpatients with major depressive disorder (MDD).
Adults meeting DSM-IV criteria for MDD with a minimum Hamilton Depression Rating
Scale (HAMD) 17-Item total score of 18 were randomized to eight weeks of
double-blind treatment with either bupropion XR (150 mg/day), venlafaxine
XR (75 mg/day) or placebo. At the end of the fourth week of treatment, a dosage
increase to bupropion XR 300 mg/day or venlafaxine XR 150 mg/day
was allowed if, in the opinion of the investigator, response was inadequate. The
primary efficacy endpoint was mean change from baseline at week 8 in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score last observation
carried forward (LOCF). Mean changes from baseline at week 8 (LOCF) in MADRS total
score were statistically significant for bupropion XR and venlafaxine XR patients
compared to the placebo group: -16.0 for bupropion XR
(P = 0.006 vs placebo), -17.1 for venlafaxine
XR (P < 0.001 vs placebo) and -13.5 for placebo.
Secondary outcomes (including CGI-S, HAM-A, MEI, Q-LES-Q-SF, responder and remitter
analyses) also improved significantly for both active treatment groups compared with
placebo. The most frequently reported adverse events were dry mouth and insomnia for
bupropion XR, and nausea, hyperhidrosis, fatigue, and insomnia for venlafaxine XR.
In this double-blind, placebo-controlled trial, bupropion XR at doses up to
300 mg/day and venlafaxine XR at doses up to 150 mg/day
demonstrated comparable antidepressant efficacy.
Key Words:
bupropion XR, depression, venlafaxine XR
First published on July 17, 2008, doi:10.1177/0269881108089602
Journal of Psychopharmacology 2009;23:531.
A more recent version of this article appeared on July 1, 2009

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