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FDA Approves Escitalopram Oxalate for Major Depressive Disorder in Adolescents NEW YORK -- March 20, 2009 -- The US Food and Drug Administration (FDA) has approved escitalopram oxalate (Lexapro) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents aged 12 to 17 years. The approval was based on 2 placebo-controlled studies. The first 8-week, flexible-dose, placebo-controlled study compared escitalopram oxalate (10 mg-20 mg/day) with placebo in patients aged 12 to 17 years. Escitalopram oxalate showed statistically significant greater mean improvement from baseline, compared with placebo, on the Children's Depression Rating Scale-Revised (CDRS-R). In the second 8-week, flexible-dose, placebo-controlled study, children and adolescents aged 7 to 17 years of age treated with racemic citalopram (20 mg-40 mg/day) showed statistically significant greater mean improvement from baseline on the CDRS-R compared with patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup. The FDA's determination of the efficacy of escitalopram oxalate in the acute treatment of MDD in adolescents was established, in part, on the basis of extrapolation from this study. Two additional flexible-dose, placebo-controlled MDD studies were conducted: 1 escitalopram oxalate study in patients aged 7 to 17 years and a citalopram study in adolescents. Neither study demonstrated efficacy on the primary efficacy parameter. Although maintenance efficacy in adolescent patients has not been systematically evaluated, the FDA in its review concluded that maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients. Escitalopram oxalate was generally well tolerated. The overall profile of adverse reactions in paediatric patients was generally similar to that seen in adult studies. SOURCE: Forest Laboratories E-mail this page to a friend or colleague! To print, use this version