New York-based pharmaceutical company Forest Laboratories has received approval from the U.S. Food and Drug Administration of its supplemental New Drug Application for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder in adolescents, 12 - 17 years of age.

Lexapro is only the second antidepressant to be approved for the treatment of Major Depressive Disorder in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.

The approval of Lexapro for the treatment of adolescent depression was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram.

In an 8-week flexible- dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12 to 17 year old patients reported in 2008, Lexapro showed statistically significant greater mean improvement from baseline, compared to placebo, on the Children's Depression Rating Scale-Revised (CDRS-R).

In another 8-week, flexible-dose, placebo-controlled study, children and adolescents 7 to 17 years of age treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared to patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup.