Sertraline hydrochloride(HCl) significantly reduced anxiety symptoms, compared to placebo, in patients with generalized anxiety disorder (GAD). The study was the first large global multi-center placebo-controlled trial to evaluate the efficacy and safety of sertraline HCl in treating GAD.

"Given that generalized anxiety disorder is a common and seemingly chronic condition that impairs life quality and increases the risk for repeated depressive episodes, it was a priority to conduct this study," said Christer Allgulander, M.D. of the Karolinska Institutet, Sweden, and lead investigator of the study. "In this study sertraline HCl was shown to be significantly more effective than placebo in treating patients with generalized anxiety disorder."

The study involved 20 investigational sites in Australia, Canada, Denmark, Norway and Sweden. A total of 370 outpatient participants with GAD (diagnosed by DSM-IV) were randomized to 12-weeks of double-blind treatment with either placebo or flexible doses of sertraline HCl (50-150 mg). The primary efficacy measure was Hamilton Anxiety Scale (HAM-A) scores. Secondary measures included scores on the Clinical Global Impression Improvement and Severity scales (CGI-I and CGI-S), Montgomery-Asberg Depression Rating Scale (MADRS), Hospital Anxiety and Depression Scale (HADS), Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) and the Endicott Work Productivity Scale (EWPS).

Additionally, sertraline HCl treatment was associated with significant improvement in both quality of life and work productivity according to Q-LES-Q and EWPS scores.

Generalized anxiety disorder affects an estimated 2.8 percent of the adult, U.S. population (approximately four million Americans). It is characterized by excessive anxiety and worry, occurring more days than not, for a period of six months or more. The worry is often unfounded or much more severe than the normal anxiety most people experience. People with this condition often worry about everyday, routine circumstances; they worry excessively about money, health, family or work, even when there are no signs of trouble. They are often unable to relax and may suffer from insomnia. Many people with GAD also have physical symptoms, such as fatigue, trembling, muscle tension, or irritability.

GAD most often strikes people in childhood or adolescence, but can begin in adulthood, too. It affects women more often than men. GAD often coexists with depression, substance abuse, or other anxiety disorders, and other conditions associated with stress, such as irritable bowel syndrome and headaches.

The most common side effects of sertraline HCl in this study (= 10 percent) include nausea, sweating, sexual side effects, diarrhea and feeling sleepy or tired. The Food and Drug Administration has not approved sertraline HCl for the treatment of generalized anxiety disorder.