Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

Abstract 

Objective

This article presents the results from a prospective, randomized, double-blind, placebo-controlled trial of escitalopram in adolescent patients with major depressive disorder.

Method

Male and female adolescents (aged 12–17 years) with DSM-IV-defined major depressive disorder were randomly assigned to 8 weeks of double-blind treatment with escitalopram 10 to 20 mg/day (n = 155) or placebo (n = 157). The primary efficacy parameter was change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score using the last observation carried forward approach.

Results

A total of 83% patients (259/312) completed 8 weeks of double-blind treatment. Mean CDRS-R score at baseline was 57.6 for escitalopram and 56.0 for placebo. Significant improvement was seen in the escitalopram group relative to the placebo group at endpoint in CDRS-R score (−22.1 versus −18.8, p = .022; last observation carried forward). Adverse events occurring in at least 10% of escitalopram patients were headache, menstrual cramps, insomnia, and nausea; only influenza-like symptoms occurred in at least 5% of escitalopram patients and at least twice the incidence of placebo (7.1% versus 3.2%). Discontinuation rates due to adverse events were 2.6% for escitalopram and 0.6% for placebo. Serious adverse events were reported by 2.6% and 1.3% of escitalopram and placebo patients, respectively, and incidence of suicidality was similar for both groups.

Conclusions

In this study, escitalopram was effective and well tolerated in the treatment of depressed adolescents. J. Am. Acad. Child Adolesc. Psychiatry, 2009;48(7):721–729.

Key Words:  depression , treatment , SSRI. Clinical trial registration information—The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00107120