Paroxetine in the Treatment of Generalized Anxiety Disorder: Results of a Placebo-Controlled, Flexible-Dosage Trial
J Clin Psychiatry 2001;62:350-357
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: The objective of this randomized,
double-blind, placebo-controlled study was to investigate the
efficacy and safety of paroxetine in outpatients with generalized
anxiety disorder (GAD).
Method: Male and female outpatients 18 years and
older who met DSM-IV criteria for GAD and had baseline scores of
at least 20 on the Hamilton Rating Scale for Anxiety (HAM-A) were
randomly assigned to treatment with paroxetine (20-50 mg/day) or
placebo for 8 weeks. The primary efficacy variable was the mean
change from baseline in the total score of the HAM-A. Additional
key efficacy variables were the change from baseline in the
scores of the HAM-A items anxious mood and tension, the anxiety
subscale of the Hospital Anxiety and Depression Scale, and the
Sheehan Disability Scale (SDS). The proportions of patients
fulfilling response and remission criteria at week 8 were also
Results: The intent-to-treat population included
324 patients. At week 8, compared with the placebo group (N =
163), the paroxetine group (N = 161) had a significantly greater
reduction of GAD symptoms on all of the above-mentioned efficacy
variables. On the HAM-A anxious mood item, which encompasses the
cardinal symptoms of GAD, significantly greater efficacy was
observed from week 1 and on the SDS significantly greater
improvement was documented in the domain "social life"
as early as week 4 for paroxetine compared with placebo. In both
the last-observation-carried-forward and completer data sets,
significantly greater proportions of paroxetine-treated patients
achieved response or remission by week 8. Treatment with
paroxetine was well tolerated, and the number and type of adverse
events recorded in the paroxetine group correspond to the known
safety profile of this medication.
Conclusion: Paroxetine in doses of 20 to 50 mg
once daily is effective in the treatment of patients with GAD.
Improvement of core symptoms of GAD occurs early and is
associated with significant reduction in disability after only 8
weeks of treatment.