Efficacy of Controlled-Release Paroxetine in the Treatment of Late-Life Depression
J Clin Psychiatry 2003;64(9):1065-1074
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Depression is the second most common
neuropsychiatric disorder in older Americans, with significant
clinical and public health costs. Despite advances in treatment,
late-life depression remains a clinical challenge. Although the
selective serotonin reuptake inhibitors (SSRIs) are the most
common pharmacologic intervention for late-life depression, few
placebo-controlled trials have assessed the efficacy of SSRIs for
Method: In this 12-week, multicenter,
placebo-controlled, flexible-dose, double-blind, randomized
trial, 319 elderly patients (mean age = 70 years) were treated
with controlled-release paroxetine (paroxetine CR) up to 50
mg/day (N = 104), immediate-release paroxetine (paroxetine IR) up
to 40 mg/day (N = 106), or placebo (N = 109). Patients met DSM-IV
criteria for major depressive disorder and had a total score of
18 or more on the 17-item Hamilton Rating Scale for Depression
(HAM-D). The primary efficacy measure was change from baseline to
endpoint in HAM-D total score.
Results: The primary efficacy analysis showed an
adjusted difference between change from baseline in HAM-D score
for paroxetine CR and placebo of -2.6 (95% confidence interval
[CI] = -4.47 to -0.73, p = .007) at the week 12
last-observation-carried-forward (LOCF) endpoint. The adjusted
difference between paroxetine IR and placebo was -2.8 (95% CI =
-4.65 to -0.99, p = .003) at week 12. Paroxetine CR and IR were
more effective than placebo, with mean ± SD endpoint HAM-D total
scores of 10.0 ± 7.41 and 10.0 ± 7.10, respectively, for the
active treatments compared with 12.6 ± 7.34 for placebo.
Response, defined as a score of 1 or 2 on the Clinical Global
Impressions-global improvement scale, was achieved by 72% of
paroxetine CR patients (LOCF; p < .002 vs. placebo), 65% of
paroxetine IR patients (p = .06 vs. placebo), and 52% of placebo
patients. Remission, defined as a HAM-D total score <= 7, was
achieved by 43% of paroxetine CR patients (LOCF; p = .009
vs. placebo), 44% of paroxetine IR patients (p = .01 vs.
placebo), and 26% of placebo patients. In a post hoc analysis,
mean HAM-D improvement for paroxetine CR and paroxetine IR was
greater than for placebo in both chronically depressed patients
(duration > 2 years) and those with short-term (<= 2 years)
depression. Dropout rates due to adverse events were 12.5% for
paroxetine CR, 16.0% for paroxetine IR, and 8.3% for placebo.
Conclusion: Paroxetine CR and paroxetine IR are
effective and well tolerated treatments for major depressive
disorder in elderly patients, including those with chronic