Double-blind, placebo-controlled evaluation of extended-release bupropion in elderly patients with major depressive disorder.
Major depressive disorder in the elderly is associated with increased morbidity and reduced quality of life. This 10 week, placebo-controlled study investigated the efficacy and tolerability of extended-release bupropion (150-300 mg once daily) in depressed patients aged 65 years or older. The statistical assumptions necessary for the validity of the protocol-specified analysis of covariance were not met for the analysis of the primary outcome variable (Montgomery-Asberg Depression Rating Scale total score at Week 10, last observation carried forward). Alternative statistical methods used for the analysis of this variable demonstrated statistical significance. Statistically significant improvements were observed on the majority of secondary end points when compared with placebo, including the health outcome measures for motivation and energy, and life satisfaction and contentment. Adverse events were generally mild to moderate and similar between treatment groups. This study demonstrated that the extended-release bupropion is an effective, well-tolerated treatment for major depression in the elderly.
Hewett
K
K
GlaxoSmithKline, Harlow, UK. Karen.Hewett@gsk.com
Chrzanowski
W
W
Jokinen
R
R
Felgentreff
R
R
Shrivastava
R K
RK
Gee
M D
MD
Wightman
D S
DS
O'Leary
M C
MC
Millen
L S
LS
Leon
M C
MC
Briggs
M A
MA
Krishen
A
A
Modell
J G
JG
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001315:Australia; D016642:Bupropion / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018765:Dopamine Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D009042:Motivation; D009656:North America; D010549:Personal Satisfaction; D015990:Placebo Effect; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D013019:South Africa; D013997:Time Factors; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D018765:Dopamine Uptake Inhibitors; D016642:Bupropion