A double-blind, parallel-group, placebo-controlled Phase III study to evaluate the safety and efficacy of Lexapro, was conducted in multiple centers across the US. The primary endpoint was change from baseline to week eight on the Children’s Depression Rating Scale-Revised (CDRS-R) using last observation carried forward (LOCF) approach.
The results suggest that Lexapro has potential as a useful treatment option for adolescents with depression. The study showed statistically significant improvement in patients treated with Lexapro relative to placebo based on the change from baseline in the CDRS-R score (-22.1 for Lexapro versus -18.8 for placebo treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated. Discontinuation rates due to adverse events were 2.6% and 0.6% for patients receiving Lexapro and placebo, respectively. Based on the results of this study, Forest plans to file for an adolescent depression indication for Lexapro this year.