On Friday Forest Laboratories announced that the FDA has approved the use of Lexapro for the treatment of depression in adolescents. From Forrest press release:

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. 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 study in adolescents. Neither study demonstrated efficacy on the primary efficacy parameter.

Given the implications of this FDA decision, next week I will start a series of posts on medication efficacy in children. But I want to share some thoughts regarding the Lexapro announcement. Some will criticize the FDA for allowing Lexapro to be used with adolescents given that only 2 of the 4 studies mentioned found significant effects of the drug when compared to placebo. But this is no different than many other FDA approvals for many other drugs. The real question is whether the risks of using Lexapro with adolescents are low enough that allowing its use in the face of conflicting data on efficacy is justified. In this case the FDA felt that the potential rewards, in terms of number of children that could potentially respond to the medication, offset the potential risks. In the abstract, I agree with the FDA. Most medications have a low response rate, and studies vary significantly in showing the medication effectiveness. The important issue here is whether the medication helps a large enough subsample of people that would justify the risks. Thus, assuming that the benefits outweigh the risks, arguing that Lexapro should not have been approved because the research is not 100% consistent, is a disservice to the thousands of depressed adolescents that may benefit from this medication.

Here is where I am excited about NIMH new strategic vision and plan. We are now moving from the simple evaluation of whether a medication is effective in large groups, to exploring the specific factors (genetics, age, social conditions, etc etc etc) that predicts whether someone (or a specific group) will respond to a medication or not. That is, we need to identify those children and adolescents who respond to the medication and understand how and why the medication is effective in that group but not in others.

Next week I will review a few studies on the risks and benefits of psychiatric medication use with children, including the controversy on suicidal risk among adolescents.

UPDATE: In light of a couple of emails I received, let me clarify something. I’m a Psychologist (not a Psychiatrist) and I do not prescribe medications. Thus, I receive no financial benefit from the use of medication by children or adolescents. In addition, I do not consult for, or have any relationship with, any pharmaceutical company. Thus, I don’t get a single dollar if the sales of any drug improve. And finally, my research is NOT paid for by any pharmaceutical or related company and I do NOT do any research on drug efficacy. I have absolutely no conflict of interests associated with this post.

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