Emerging Drug Options: Adolescent Depression

Approximately 2 million adolescents between the ages 12 and 17 in the United States have suffered a serious bout of depression within the past year. Major depressive disorder (MDD) in adolescents is debilitating; about half of these patients will have continued problems with depression as they enter adulthood. Compounding the problem is the fact that few treatment options have been effective and well-tolerated in this patient group. In March 2009, the FDA approved a supplemental New Drug Application for escitalopram (Lexapro, Forest Laboratories, Inc.) as acute and maintenance treatment for MDD in adolescents aged 12 to 17. The SSRI is only the second antidepressant to be approved for the treatment of MDD in adolescents, the first of which was fluoxetine (Prozac, Eli Lilly and Co.). Encouraging Data After observing improvements in adults with MDD taking escitalopram, investigators more recently undertook several studies to assess efficacy in adolescents with MDD. The FDA’s most recent approval for use in adolescent depression was supported by two placebo-controlled studies, one conducted in adolescents taking the drug and the other conducted in children and adolescents taking citalopram (Celexa, Forest Laboratories, Inc.). In an 8-week flexible-dose, placebo-controlled study that compared escitalopram 10 mg/day or 20 mg/day to placebo in adolescents in 2008, those receiving escitalopram had statistically significant greater improvements from baseline when compared with placebo, based on the Children’s Depression Rating Scale-Revised (CDRS-R). In another 8-week, flexible-dose, placebo-controlled study, children and adolescents aged 7 to 17 treated with racemic citalopram 20 mg/day or 40 mg/day had statistically significant greater improvements from baseline on the CDRS-R when compared with patients treated with placebo. Positive results...