Efficacy and Tolerability of Controlled-Release and Immediate-Release Paroxetine in the Treatment of Depression
J Clin Psychiatry 2002;63:577-584
© Copyright 2014 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: Antidepressant efficacy may
be compromised by early discontinuation of
treatment secondary to common, treatment-emergent side
effects, including nausea, agitation, and
somnolence. Paroxetine controlled-release (CR) was developed
to improve general tolerability and, in particular,
Objective: To determine the antidepressant
efficacy and tolerability of paroxetine CR in adult
patients 18 to 65 years of age with DSM-IV major
Method: Paroxetine CR (25-62.5 mg/day; N
= 212) and paroxetine immediate-release (IR; 20-50 mg/day; N = 217) were compared with placebo (N
= 211) in the pooled dataset from 2 identical,
double-blind, 12-week clinical trials.
Results: Both paroxetine CR and paroxetine
IR exhibited efficacy in major depressive disorder
as assessed by the reduction in 17-item Hamilton
Rating Scale for Depression total score compared
with placebo. Moreover, depressed mood and psychic anxiety symptoms improved as early as
treatment week 1 in the paroxetine CR group compared
with the placebo group. After 6 weeks of treatment,
response and remission rates were 41.5% and 20.5% for placebo, 52.8% and 29.6% for paroxetine IR,
and 58.9% and 34.4% for paroxetine CR,
respectively. After 12 weeks of treatment, response and
remission rates were 61.2% and 44.0% for placebo, 72.9%
and 52.5% for paroxetine IR, and 73.7% and 56.2%
for paroxetine CR, respectively. Rates of nausea
were significantly lower for paroxetine CR (14%) than
for paroxetine IR (23%; p <= .05) during week 1.
Rates of dropout due to adverse events were
comparable between paroxetine CR and placebo, while
significantly (p = .0008) more patients treated with
paroxetine IR withdrew from the study prematurely
compared with those treated with placebo.
Conclusion: Paroxetine CR is an effective
and well-tolerated antidepressant exhibiting
symptomatic improvement as early as week 1. Paroxetine CR
is associated with low rates of early-onset nausea
and dropout rates due to adverse events comparable
to those of placebo. The clinical improvement seen
with paroxetine CR, coupled with its favorable
adverse event profile, suggests a benefit for therapeutic
outcome with paroxetine CR.