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Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial.

Author(s): Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S

Affiliation(s): University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-8589, USA. graham.emslie@utsouthwestern.edu

Publication date & source: 2009-07, J Am Acad Child Adolesc Psychiatry., 48(7):721-9.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2009-10-20

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