Efficacy of Controlled-Release Paroxetine in the Treatment of Late-Life Depression
J Clin Psychiatry 2003;64(9):1065-1074
© Copyright 2015 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
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