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Paroxetine Safe, Effective in Generalized Anxiety Disorder

  • Authors:
  • CME Released: 4/22/2003
  • Valid for credit through: 4/22/2004, 11:59 PM EST
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Target Audience and Goal Statement

This activity is intended for primary care physicians, psychiatrists, and other specialists who treat patients with GAD.

The goal of this activity is to provide the latest medical news to physicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Review the diagnosis of GAD and the effects of psychotropic agents on this condition.
  • Describe the results of the study comparing the efficacy of paroxetine compared with placebo in the treatment of patients with GAD.



This article may discuss investigational products or unapproved uses of products regulated by the U.S. Food and Drug Administration.


  • Laurie Barclay, MD

    Laurie Barclay is a freelance reviewer and writer for Medscape.


    Disclosure: Dr. Barclay has reported no significant financial interests.

CME Author(s)

  • Bernard M. Sklar, MD, MS

    Writer for Medscape Medical News


    Disclosure: Dr. Sklar has disclosed that he has served as a consultant for Schering-Plough.

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Paroxetine Safe, Effective in Generalized Anxiety Disorder


CME Released: 4/22/2003

Valid for credit through: 4/22/2004, 11:59 PM EST


April 22, 2003 — Paroxetine is effective and well-tolerated in patients with generalized anxiety disorder (GAD), according to the results of a double-blind, placebo-controlled trial published in the April issue of the American Journal of Psychiatry. Selective serotonin reuptake inhibitors (SSRIs) are widely used for anxiety disorders, but controlled trials are scant for most.

"Despite the widespread use of SSRIs for the treatment of depression and anxiety disorders, paroxetine is the only agent of this class to have been investigated for the treatment of generalized anxiety disorder," write Karl Rickels, from the University of Pennsylvania Medical Center in Philadelphia, and colleagues.

Inclusion criteria for this study of 566 outpatients were GAD, no other axis I disorder, score of at least 20 on the Hamilton Rating Scale for Anxiety, and score of at least 2 on the anxious mood and tension items. After a one-week placebo run-in phase, patients were randomized to eight weeks of treatment with paroxetine, 20 or 40 mg/day, or placebo.

Compared with the placebo group, reductions in total Hamilton anxiety scale scores were significantly greater for both paroxetine groups. Rate of response, defined as a rating of "very much improved" or "much improved" on the Clinical Global Impression global improvement measure, was 62% in the 20-mg paroxetine group, 68% in the 40-mg paroxetine group, and 46% in the placebo group. Rate of remission, defined as a posttreatment Hamilton anxiety scale score of 7 or less, was 30% in the 20-mg paroxetine group, 36% in the 40-mg paroxetine group, and 20% in the placebo group.

There was significantly greater improvement with paroxetine than with placebo for all three domains of the Sheehan Disability Scale. Paroxetine was well tolerated at both doses.

"Given the evidence that in primary practice up to 75% of generalized anxiety disorder cases coexist with depression or another anxiety disorder, we are aware of the fact that many physicians will infrequently see cases of pure generalized anxiety disorder," the authors write. "Because of this situation, the development of rational approaches to treating pure and comorbid GAD will require further epidemiological investigations concerning the influence of prior or comorbid psychiatric and somatic illness on treatment outcomes."

GlaxoSmithKline supported this study.

Am J Psychiatry. 2003;160:749-756