Escitalopram Approved for Treatment of Major Depressive Disorder in Adolescents

Emma Hitt, PhD

March 24, 2009

March 23, 2009 — Escitalopram oxalate (Lexapro, Forest Laboratories, Inc) has been approved by the US Food and Drug Administration (FDA) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents aged 12 to 17 years.

Escitalopram was approved based on data from 2 flexible-dose, placebo-controlled trials that each lasted 8 weeks. One trial was conducted in adolescents aged 12 to 17 years and compared escitalopram with placebo. The other trial was conducted in children and adolescents aged 7 to 17 years and compared citalopram with placebo.

Both studies showed a significant improvement in the Children's Depression Rating Scale–Revised (CDRS-R) in the treatment group compared with the placebo group. In the trial of children and adolescents, the greatest benefit was observed in the adolescent group

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Two additional flexible-dose, placebo-controlled MDD studies — 1 with escitalopram in patients ages 7 to 17 and 1 with citalopram in adolescents — failed to demonstrate a significant benefit in the primary endpoint.

The FDA review concluded that maintenance efficacy could be extrapolated from data in adults, although maintenance efficacy has not been systemically evaluated in adolescents.

"Adolescent depression can often be challenging to treat because there are limited treatment options that are proven to be effective and well-tolerated in this patient population," noted Graham Emslie, MD, professor of psychiatry at the University of Texas Southwestern Medical Center in Dallas, in an FDA news release.

Escitalopram represents the second antidepressant to be approved for major depressive disorder in adolescents.

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