Escitalopram shows promise in reducing symptoms of depression in adolescents with major depressive disorder, according to preliminary phase III trial results released by the manufacturer; presentation of full data is anticipated next year.

The phase III study evaluated safety and efficacy of escitalopram compared with placebo in treatment of adolescents age 12 to17 years with major depressive disorder. During the eight-week study, 316 patients were randomized to escitalopram 10-20 mg or placebo.

The primary endpoint was change from baseline to Week 8 on the Children's Depression Rating Scale - Revised (CDRS-R) using last observation carried forward approach. The study showed statistically significant improvement in patients treated with the antidepressant relative to placebo.

Preliminary data also indicate that escitalopram was generally well-tolerated. Overall premature discontinuation rates (all causes including adverse events) were 19 percent for the antidepressant and 15 percent for patients receiving placebo.

The CDRS-R is a commonly used clinician-rated instrument that covers 17 symptom areas of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem.

Researchers estimate that up to eight percent of adolescents are affected by depression. However, in the U.S., FDA-approved treatment options for this population are limited. Escitalopram is not currently approved by the FDA for use in pediatric patients.

"Depression is a significant problem among adolescents, and frequently goes under-recognized and under-treated in this age group. These data support that escitalopram has potential as an effective treatment option for adolescents with depression," said Ivan Gergel, MD, Senior Vice President of Scientific Affairs and President of the Forest Research Institute.