Lexapro Improves Depression Symptoms In Adolescents
Forest Laboratories's 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 percent 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 pediatric 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 centers across the U.S. A total of 316 patients entered the eight week study, receiving either Lexapro 10-20 mg (n=158) or placebo (n=158). 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 (-22.1 for Lexapro vs. -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 percent and 0.6 percent for patients receiving Lexapro and placebo, respectively. Serious adverse events were reported by 2.6 percent of patients receiving Lexapro 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 in Lexapro patients vs. 26 percent with placebo), menstrual cramps (11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury (9 percent vs. 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 Lexapro treated patients twice that of placebo treated patients was influenza-like symptoms (7 percent vs. 3 percent placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss of interest in usual activities. While the brain chemistry of depression is not fully understood, research suggests that depression is caused by an imbalance of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental disorders in adolescents, depression in this population remains under-treated. Depression is a chronic disease that requires medical attention and treatment, and if left untreated, may have serious consequences. According to the National Alliance on Mental Illness (NAMI), adolescents with untreated depression are likely to have ongoing problems in school, at home and with their friends.
For adolescents who suffer from depression, psychotherapy, cognitive-behavior therapy, interpersonal therapy and medication play an important role in the management of their illness. Patients on antidepressant treatment should also be closely monitored by healthcare providers, family members and other caregivers.