Escitalopram significantly improves symptoms of depression in adolescents and is tolerated well compared with placebo, according to phase III study results presented at the annual meeting of the American Psychiatric Association.

The study involved 316 patients age 12 to 17 years with major depressive disorder (MDD). The double-blind, parallel-group, placebo-controlled trial was conducted in multiple centers across the U.S. Patients in the eight-week study were randomized to escitalopram 10-20 mg or placebo.

Primary endpoint was change from baseline to Week 8 on the Children's Depression Rating Scale - Revised (CDRS-R) using last observation carried forward (LOCF) approach. 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. The study showed statistically significant improvement in patients treated with escitalopram relative to placebo based on the change from baseline in the CDRS-R score (-22.1 for escitalopram versus -18.8 for placebo treatment).

The trial also showed that escitalopram was generally well-tolerated. Discontinuation rates due to adverse events were 2.6 percent and 0.6 percent for patients receiving escitalopram and placebo, respectively. Serious adverse events were reported by 2.6 percent of patients receiving escitalopram and 1.3 percent for patients receiving placebo.

The most commonly reported adverse events (greater than 10 percent in either group) were headache (25 percent with escitalopram versus 26 percent with placebo), menstrual cramps (11 percent versus 15 percent placebo), nausea (10 percent versus 8 percent placebo), insomnia (10 percent versus 6 percent placebo) and inflicted injury (9 percent versus 13 percent placebo), the majority of which were accidental in nature.

The only adverse event occurring at a frequency of greater than or equal to 5 percent and with an incidence for escitalopram-treated patients twice that of placebo treated patients was influenza-like symptoms (7 percent versus 3 percent placebo).

"Treating depression in adolescents can be particularly challenging because few antidepressants have demonstrated efficacy in clinical trials in this population," said Graham Emslie, MD, Professor of Psychiatry at the University of Texas Southwestern Medical Center in Dallas. "In this study, Lexapro (escitalopram) significantly improved depressive symptoms in adolescents with MDD, and was also well tolerated by study participants."