Depression, Adolescents, and Antidepressants

Earlier this month, the Food and Drug Administration (FDA) approved Lexapro (escitalopram oxalate) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents 12- to 17-years-old.

Here's some basic information about the approval from a Forest Laboratories press release (I have put some parts in bold for added attention):

"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 (Celexa). 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 (Celexa) 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. The FDA's determination of the efficacy of Lexapro 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: one Lexapro study in patients ages 7 to 17 and one citalopram (Celexa) 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..."

This approval has sparked a wave of controversy, especially in light of a five-year probe by the Justice Department that, last month, culminated in accusations of Forest attempting to sway pediatricians to prescribe Celexa and Lexapro. The prosecutors allege that Forest offered doctors inducements including spa visits, fishing trips, and tickets to Broadway shows and sports events (before this Lexapro approval). Prosecutors have also accused Forest of ignoring a study that showed Celexa to be ineffective for pediatric use, encouraging sales staff to promote another, more positive study.

For purposes of discussion, it should be noted that Lexapro and many other antidepressants already carries this black box warning: