US group Forest Laboratories and Danish partner Lundbeck’s Lexapro has met its endpoint in a late-stage trial in adolescents with depression; consequently, the companies are expecting to file the drug use in this age group next year.

The double-blind, placebo-controlled Phase III trial of Lexapro (escitalopram oxalate) was designed to assess its safety and efficacy as a treatment for adolescents (aged 12-17 years) with major depressive disorder.

During the eight-week study, 316 patients were randomised to receive either Lexapro or a ghost pill. It was found that those in the treatment group experienced a statistically-significant improvement in the symptoms of depression, as measured by the Children’s Depression Rating Scale-Revised, which has been designed to be relevant to adolescents and includes pointers such as impaired school work and difficulty having fun.

Importantly, the trial also showed that Lexapro was well-tolerated in this age group, with the premature drop-out rate 19% in the treatment group and 15% in the placebo arm, the companies noted.

‘Potential’ for adolescent MDD
Ivan Gergel, senior vice president of scientific affairs and president of the Forest Research Institute, said that, based on the success of the trial and positive results of previous studies, “we see potential for Lexapro, already established as an effective treatment for adults with depression, as a treatment for adolescents with MDD.”

“Subject to ongoing communication with the FDA and our review of the full study results for the just completed trial, we intend to file in 2008 for an adolescent depression indication for Lexapro,” he added.