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Escitalopram Lowers Depression Scores in Adolescent Patients: Presented at APA

By Charlene Laino

WASHINGTON, DC -- May 12, 2008 -- Treatment with escitalopram oxalate appears to result in clinically meaningful improvements in adolescent patients with depression, suggest results of a phase 3, randomized, double-blind, placebo-controlled trial.

Graham Emslie, MD, Professor of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, presented the findings here on May 7 at the 161st Annual Meeting of the American Psychiatric Association (APA).

The researchers randomized patients aged 12 to 17 years who were diagnosed with major depressive disorder to treatment with escitalopram or placebo for 8 weeks. The dosage of escitalopram was fixed at 10 mg/day for the first 3 weeks of treatment, after which it could be increased to 20 mg/day.

The primary endpoint was the change from baseline to week 8 on the Children's Depression Rating Scale-Revised (CDRS-R). The mean baseline CDRS-R score was 57.6 in the escitalopram arm and 56.0 in the placebo arm.

A total of 133 (84.7%) patients on placebo and 126 (81.3%) patients on escitalopram completed 8 weeks of double-blind treatment. There were no statistically significant differences between the treatment groups in the reason for premature discontinuation.

At 8 weeks, the CDRS-R score had decreased by 22.4 points in the escitalopram arm and by 18.4 points in the placebo arm (P = .022).

The drug was generally well tolerated, Dr. Emslie said. The most commonly reported adverse events were headache (25% vs 26%), menstrual cramps (11% vs 15%), nausea (10% vs 8%), and insomnia (10% vs 6%).

Six (3.8%) placebo patients and 6 (3.9%) escitalopram patients had an adverse event during double-blind treatment that was considered by the investigator to be suggestive of self-harm. No patient in either group attempted suicide; 3 (2%) placebo-treated patients and 1 (1%) escitalopram-treated patient experienced suicidal ideation.

"Currently, only half of patients in this age group respond to first-line therapy, so we need alternative choices," Dr. Emslie said.

He added, "By its nature, escitalopram has fewer drug-drug interactions than most other drugs. It doesn't affect the liver enzymes as they are being metabolized, as many other antipsychotics and nonantipsychotics do," he said.

Funding for this study was provided by Forest Laboratories.

[Presentation title: Escitalopram in the Treatment of Adolescent Depression. Abstract NR6-055]

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