Objective: Escitalopram is a selective serotonin reuptake inhibitor antidepressant indicated for use in adults. This trial examined the efficacy and safety of escitalopram in pediatric depression.
Method: Patients (6-17 years old) with major depressive disorder were randomized to receive 8 weeks of double-blind flexibly dosed treatment with escitalopram (10-20 mg/day; n = 131) or placebo (n = 133). Randomization was not stratified by age. The primary efficacy measure was the mean change from baseline to endpoint in Children's Depression Rating Scale-Revised (CDRS-R) scores, using the last observation carried forward approach.
Results: A total of 82% of patients completed treatment. Escitalopram did not significantly improve CDRS-R scores compared to placebo at endpoint (least squares mean difference = -1.7, p = .31; last observation carried forward). In a post hoc analysis of adolescent (ages 12-17 years) completers, escitalopram significantly improved CDRS-R scores compared with placebo (least squares mean difference = -4.6, p = .047). Headache and abdominal pain were the only adverse events in >10% of patients in the escitalopram group. Discontinuation rates caused by adverse events were 1.5% for both groups. Potential suicide-related events were observed in one escitalopram- and two placebo-treated patients. There were no completed suicides.
Conclusions: Although there were no significant differences between escitalopram and placebo in the total population, the data suggest that escitalopram may have beneficial effects in adolescent patients. Escitalopram appeared to be well tolerated.