Efficacy and Tolerability of Controlled-Release and Immediate-Release Paroxetine in the Treatment of Depression
J Clin Psychiatry 2002;63(7):577-584
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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.