Escitalopram: in the treatment of major depressive disorder in adolescent patients

Abstract

Escitalopram is a selective serotonin reuptake inhibitor (SSRI), and is the second antidepressant to be approved for use in treating major depressive disorder (MDD) in adolescent patients (aged 12-17 years) in the US. In a randomized, double-blind, flexible-dose, multicenter trial, once-daily escitalopram 10-20 mg (n = 154) for 8 weeks was significantly better than placebo (n = 157) in improving the severity of depressive symptoms (as assessed by the change in the Children's Depression Rating Scale-Revised [CDRS-R] total score) in adolescent patients with MDD. Preliminary data from a combined analysis of the double-blind data from this trial and double-blind data from a 16-week, fixed-dose, extension study suggest a significant difference between escitalopram and placebo recipients in the change in CDRS-R total scores after 24 weeks of treatment. In a similarly designed flexible-dose trial in pediatric patients (aged 6-17 years), a significant difference between once-daily escitalopram 10-20 mg (n = 77) and placebo (n = 80) for 8 weeks, as assessed by the change in CDRS-R total score, was not shown in the primary analysis (i.e. patients of all ages). In a pre-specified subgroup of adolescent patients, no significant difference was shown between the escitalopram and the placebo groups when analyzed using the last observation carried forward method, but was shown using the observed case method. Escitalopram 10-20 mg/day showed better efficacy than placebo for some secondary endpoints (e.g. the change in the Clinical Global Impression [CGI]-Severity score, the CGI-Improvement response rate) but not others (e.g. CDRS-R response rate, rate of remission) [corrected].Once-daily escitalopram 10-20 mg for 8 weeks was generally well tolerated in clinical trials in adolescent or pediatric patients with MDD. The incidence of suicidality-related adverse events was generally similar between escitalopram and placebo recipients.