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Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
Date:11/29/2007

efficacy of LEXAPRO in the treatment of depressed adolescents, aged 12-17, was conducted in multiple centers across the U.S. During the eight week study, 316 patients were randomized to receive 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 study showed statistically significant improvement in patients treated with LEXAPRO relative to placebo (p=0.022).

The trial also showed that LEXAPRO was generally well-tolerated. Overall premature discontinuation rates (all causes including adverse events) were [19%] for patients receiving LEXAPRO and [15%] for patients receiving placebo.

Future Development Plans

"Based on these positive results and results of other studies, we see potential for LEXAPRO, already established as an effective treatment for adults with depression, as a treatment for adolescents with MDD. Subject to ongoing communication with the FDA and our review of the full study results for the just completed trial, we intend to file in 2008 for an adolescent depression indication for LEXAPRO," said Ivan Gergel, M.D.

Depression and Adolescents

Adolescent depression is characterized by persistent sadness and loss of interest in usual activities.(3) While the brain chemistry of depression is not fully understood,(4) research suggests that depression is caused by an imbalance of certain chemicals in the brain, most notably serotonin.(5)

Despite advances and progress in identifying and treating mental disorders in adolescents, epidemiologic studies indicate that only 20-35 percent of depressed patients in this age group currently receive treatment.(6) Depression is a chronic disease(3) that requires medical attention and treatment, and if left untreated, may have serious consequences.(7)

For adolescents who suffer from depression, psychoth
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SOURCE Forest Laboratories, Inc.
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