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Study Demonstrates Lexapro(R) Significantly Improves Depression Symptoms in Adolescents
Date:5/7/2008

parallel-group, placebo-controlled phase III study to evaluate the safety and efficacy of Lexapro in the treatment of depressed adolescents, aged 12-17, was conducted in multiple centers across the U.S. A total of 316 patients entered the eight week study, receiving either Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was change from baseline to Week 8 on the Children's Depression Rating Scale - Revised (CDRS-R) using last observation carried forward (LOCF) approach. The CDRS-R is a commonly used clinician-rated instrument that covers 17 symptom areas of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem. The study showed statistically significant improvement in patients treated with Lexapro relative to placebo based on the change from baseline in the CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo treatment; p=0.022).

The trial also showed that Lexapro was generally well-tolerated. Discontinuation rates due to adverse events were 2.6 percent and 0.6 percent for patients receiving Lexapro and placebo, respectively. Serious adverse events were reported by 2.6 percent of patients receiving Lexapro and 1.3 percent for patients receiving placebo. The most commonly reported adverse events (greater than 10 percent in either group) were headache (25 percent in Lexapro patients vs. 26 percent with placebo), menstrual cramps (11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury (9 percent vs. 13 percent placebo), the majority of which were accidental in nature. The only adverse event occurring at a frequency of greater than or equal to 5 percent and with an incidence for Lexapro treated patients twice that of placebo treated patients was influenza-like symptoms (7 percent vs. 3 percent placebo).

Depression and Adolescents

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SOURCE Forest Laboratories, Inc.
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