To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: APA: Results From A New Study Show Zoloft (Sertraline) Effective In Treatment Of Social Anxiety Disorder URL: http://www.pslgroup.com/dg/2156A6.htm Doctor's Guide May 21, 2002
PHILADELPHIA, PA -- May 21, 2002 -- Zoloft® (sertraline hydrochloride) was significantly more effective than placebo in reducing the fear, anxiety and avoidance behavior experienced by patients with social anxiety disorder, also known as social phobia, according to data presented today at the American Psychiatric Association (APA) annual meeting. In this study, treatment with Zoloft also was associated with significant improvements in patient functioning and quality-of-life. Pfizer Inc filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration in January 2002 for Zoloft for the treatment of social phobia. Zoloft is currently indicated for the treatment of major depressive disorder, posttraumatic stress disorder (PTSD), panic disorder and obsessive-compulsive disorder (OCD). This double-blind, placebo-controlled, multicenter clinical trial involved 15 outpatients with a primary diagnosis of generalized social anxiety disorder. Study participants had a mean baseline score on the Liebowitz Social Anxiety Scale (LSAS) of 93, representing moderate-severe social anxiety disorder (entry criteria LSAS score greater than to or equal to 68), and a mean Clinical Global Impression-Severity Scale (CGI-S) score of 4.8 +/- 0.7. Patients were randomized to 12 weeks of double-blind treatment with either a flexible dose of Zoloft (50-200 mg) or placebo. The LSAS Total Score mean change demonstrated that patients treated with Zoloft experienced a significant reduction in fear/anxiety and avoidance symptoms compared to patients who received placebo(-35.0 vs. -21.4; p<0.001). The data also indicate that patients who completed 12 weeks of treatment in the Zoloft group had Clinical Global Impression-Improvement (CGI-I) ratings less than or equal to 2, indicating that the patients were "much" or "very much improved" as compared to patients in the placebo group (55.6 percent vs. 29.5 percent; p<0.001). CGI-I is a physician global assessment of the patient's improvement since the pre-treatment baseline of the study. Results also showed that Zoloft was significantly superior to placebo on most secondary efficacy measures, including quality of life and functioning as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire and the Sheehan Disability Inventory (SDI). Zoloft was well-tolerated overall, with a discontinuation rate that was not significantly different from placebo. "The results from this study demonstrate that patients, even those with extremely high levels of symptom severity and impairment, are responsive to treatment with Zoloft," said Michael R. Liebowitz, MD, Director of the Anxiety Disorders Clinic at the New York State Psychiatric Institute and Professor of Clinical Psychiatry at Columbia College of Physicians and Surgeons. Social anxiety disorder, one of the three most common psychiatric disorders in the United States, is characterized by a marked and persistent fear and avoidance of social or performance situations in which the person is likely to feel humiliated or embarrassed. The condition is diagnosed only if the avoidance, fear or anxiety experienced in anticipation of the social or performance situation interferes significantly with the person's daily routine, occupational functioning, or social life, or if the person is markedly distressed about having the phobia. The more disabling form of the disorder is generalized social anxiety disorder, in which a person experiences extreme fear and anxiety in most social and performance situations (e.g., initiating or maintaining conversations, working while being observed, taking tests and even eating in public places). Individuals with generalized social anxiety disorder may be more likely to manifest deficits in social skills and to have severe social and work impairment. Zoloft is not currently approved to treat social anxiety disorder. Zoloft is indicated for depression, posttraumatic stress disorder (PTSD), panic disorder (with or without agoraphobia), and obsessive-compulsive disorder (OCD). It has been shown to be safe for long-term use in the treatment of pediatric OCD when used as prescribed. Zoloft is the first and only FDA-approved therapy for the long-term treatment of PTSD. Zoloft is the most prescribed brand of its kind in the United States and is available in 96 countries around the world. Since its approval more than a decade ago, millions of people have been treated with Zoloft. Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) medicine. Patients should never take Zoloft at the same time as an MAOI. Patients must wait at least two weeks before switching from Zoloft to an MAOI or from an MAOI to Zoloft. Zoloft is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in Zoloft. Some people taking Zoloft may have side effects. The most common side effects of Zoloft include upset stomach, having trouble sleeping, diarrhea, dry mouth, sexual side effects, feeling unusually sleepy or tired, tremor, indigestion, increase of sweating, feeling agitated and decreased appetite. In clinical studies with Zoloft, few patients were bothered enough by side effects to stop taking their medicine. Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best known consumer products. SOURCE: Pfizer Inc --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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