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Title: Escitalopram Effective in Social Anxiety Disorder for Up to 36 Weeks: Presented at ADAA

"Escitalopram Effective in Social Anxiety Disorder for Up to 36 Weeks: Presented at ADAA"

By Alison Palkhivala TORONTO, ON -- March 31, 2003 -- A multinational trial confirmed that escitalopram has long-term efficacy for treatment of social anxiety disorder up to at least 36 weeks. Lead author Stuart A. Montgomery, MD, of Imperial College, London, England, and colleagues enrolled 413 patients with social anxiety disorder in a 12-week, open-label trial in which they took 10 to 20 mg/day of escitalopram. Prior to initiation of therapy, all patients had Liebowitz Social Anxiety Scale (LSAS) scores of 70 or more. Dr. Montgomery presented the results here in a poster on March 29th at the 23rd Annual Conference of the Anxiety Disorders Association of America. The 372 patients who responded to this therapy were then randomized to continued treatment with escitalopram or a placebo. Responders to the 12-week open-label period by definition obtained a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement (CGI-I). By the end of the open-label period these patients also improved significant on their LSAS total and subscale scores as well as CGI-Severity (CGI-S), Sheehan Disability Scale (SDS) and Montgomery-Asberg Depression Rating Scale (MADRS) scores. During the randomization period, patients who continued to take escitalopram took significantly longer to relapse than patients taking placebo. Relapse was defined as a 10 or greater increase in LSAS score or withdrawal from the study due to lack of efficacy. More than twice as many patients in the placebo group relapsed, compared with those taking escitalopram (50% vs. 22%, P<0.001). The risk of relapse was 2.8 times greater in the placebo group compared with the escitalopram group (P<0.0001). Significantly more escitalopram-treated patients completed the study (66% vs. 44%, P<0.001). Escitalopram patients continued to improve with respect to mean CGI score, all three subscales of the SDS, and total LSAS score as well as scores on the avoidance and fear-anxiety LSAS subscales during the double-blind portion of the trial. Similar improvements were not seen in placebo patients. Overall, escitalopram was well tolerated. Side effects that occurred in 5% or more patients more than 1 week after randomization included headache, influenza-like symptoms, fatigue and rhinitis. There were no significant changes in vital signs, electrocardiograms or weight. "This is a study extending the efficacy [of escitalopram] in depression into the anxiety disorders," said Dr. Montgomery. "We've now done two studies acutely with escitalopram against placebo in social anxiety disorder, and this is the long-term treatment study indicating that it works -- it works in short-term treatment, and it works in long-term treatment." This research received support from H. Lundbeck A/S, European manufacturers of escitalopram. [Study title: Escitalopram Prevents Relapse in Patients Suffering from Social Anxiety Disorder (SAD). P119]

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