Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial
Emslie GJ et al. - Escitalopram was effective and well tolerated in the treatment of depressed adolescents. Methods- 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.
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