Childhood and Adolescent Depression

The subject of the role of paroxetine in the treatment of depression in children and adolescents has been one of great controversy and media attention. On June 19, 2003, the FDA released a statement regarding a possible increased risk of suicidal thinking and suicide attempts in children and adolescents 18 years of age and younger treated with paroxetine for major depressive disorder (U.S. Food and Drug Administration 2003). The statement was based on data from three well-controlled unpublished studies, each showing no benefit for paroxetine above placebo in the treatment of pediatric depression. In addition to the lack of demonstrable efficacy for paroxetine, the data were troubling in that they revealed a two- to threefold increase in suicidal ideation and suicide attempts for paroxetine compared with placebo (3.4% and 1.2%, respectively).

These data contrasted with those of an earlier study supporting the efficacy of paroxetine in the treatment of depression in this population. Keller et al. (2001) conducted a randomized, double-blind study of adolescents (ages 12-18 years) that compared paroxetine with placebo. Paroxetine demonstrated a significant advantage over placebo in most, but not all, outcome variables. It is, however, notable that they reported a rate of suicidal behavior/ideation in the paroxetine group of 5.4%; the rate of the placebo arm was not contained in the report.

More recently, Emslie et al. (2006) reported that paroxetine was no more efficacious than placebo in the treatment of pediatric depression. Using the Children's Depression Rating Scale—Revised, they found that at week 8 of treatment, the total adjusted mean changes in score from baseline for patients receiving paroxetine and placebo were -22.58 and 23.38 points, respectively. In this trial, rates of suicidal ideation and behavior were comparable between the paroxetine (1.92%) and placebo (0.98%) groups. An important distinction between the above-mentioned studies was that Emslie et al. (2006) used lower doses of paroxetine than did Keller et al. (2001); mean dosages were 20.4 and 28 mg/day, respectively. This difference is highly relevant, given that paroxetine has been shown to exhibit marked nonlinear kinetics in children. Findling et al. (1999) showed that an increase in dosage from 10 to 20 mg results in a sixfold increase in child serum paroxetine levels.

The FDA's black box warning concerning antidepressant use and suicidality risk in children and adolescents has already had a major adverse impact on SRI prescribing in the under-18 age group (Nemeroff et al. 2007). For the first time in a decade, an increase in teenage suicide rates has been noted, perhaps due to the decrease in antidepressant prescribing.

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