Author(s): Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S
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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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00107120.
This article was published in J Am Acad Child Adolesc Psychiatry
and referenced in Journal of Psychology & Psychotherapy