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Drug approved for adolescents with depression
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The FDA has approved escitalopram oxalate (Lexapro, Forest) to treat major depressive disorder in people aged 12-17, just weeks after a U.S. Justice Department complaint that the drug was improperly being marketed to younger patients.
The FDA approval was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram (Celexa). In an eight-week flexible-dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12- to 17-year-old patients, Lexapro showed statistically significant greater mean improvement from baseline compared with placebo on the Children’s Depression Rating Scale-Revised (CDRS-R).
In another eight-week, flexible-dose, placebo-controlled study, children and adolescents between the ages of 7 and 17 treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared with patients treated with placebo. Effectiveness was not shown in another pair of studies, however, Forest officials noted in a press release.