Forest Laboratories, Inc. announced that study results show Lexapro (escitalopram oxalate) significantly improved symptoms of depression as compared to placebo treatment and was well tolerated in adolescents, aged 12-17, with major depressive disorder (MDD), according to phase III data presented at the 2008 Annual Meeting of the American Psychiatric Association. These results suggest that Lexapro has potential as a useful treatment option for adolescents with depression. Top-line results of this study were initially released in November 2007.
"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 significantly improved depressive symptoms in adolescents with MDD, and was also well tolerated by study participants".
Researchers estimate that up to eight per cent of adolescents are affected by depression. Depression is a chronic disease that requires medical treatment. However, FDA-approved treatment options for this population are limited. Lexapro is not currently approved by the FDA for use in paediatric or adolescent patients.
Based on the results of this study, Forest plans to file for an adolescent depression indication for Lexapro this year. A double-blind, parallel-group, placebo-controlled phase III study to evaluate the safety and efficacy of Lexapro in the treatment of depressed adolescents, aged 12-17, was conducted in multiple centres across the US. A total of 316 patients entered the eight week study, receiving either Lexapro 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 (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 Lexapro relative to placebo based on the change from baseline in the CDRS-R score.
Lexapro is an SSRI being studied as a treatment for adolescents with MDD. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder (GAD) in adults.
Lexapro is thought to work by helping to restore the brain's chemical balance. It is believed to increase the availability of serotonin, a substance in the brain believed to influence mood. In adults, Lexapro 10 mg/day is a well-tolerated therapy, with drop-out rates due to adverse events comparable to placebo treatment in depression trials. Lexapro has been prescribed to over 16 million people.