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news.Forest Laboratories and H Lundbeck have reported positive preliminary top-line results from a double-blind, placebo-controlled Phase III study of Lexapro in the treatment of adolescents, aged 12 to 17, with major depressive disorder.
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These results show that patients treated with Lexapro experienced statistically significant improvement in symptoms of depression, as measured by the study’s primary endpoint, the children’s depression rating scale-revised (CDRS-R), compared to placebo. 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.
Ivan Gergel, senior vice president of scientific affairs and president of the Forest Research Institute, said: “Depression is a significant problem among adolescents, and frequently goes under-recognized and under-treated in this age group. These data support that Lexapro has potential as an effective treatment option for adolescents with depression.”