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Double-Blind, Randomized, Placebo-Controlled Trial of Escitalopram in the Treatment of Pediatric Depression

NCJ Number
213520
Journal
Child & Adolescent Psychiatry Volume: 45 Issue: 3 Dated: March 2006 Pages: 280-288
Author(s)
Karen D. Wagner Ph.D.; Jeffrey Jonas M.D.; Robert L. Findling M.D.; Daniel Ventura Ph.D.; Khalil Saikali Ph.D.
Date Published
March 2006
Length
9 pages
Annotation
This trial examined the effectiveness and safety of the medicine escitalopram in treating depression in children; escitalopram is a selective serotonin reuptake inhibitor that is used to treat major depressive disorder in adults.
Abstract
A total of 82 percent of the patients completed the prescribed treatment. Escitalopram did not significantly improve children's scores on the Children's Depression Rating Scale-Revised (CDRS-R) compared to the sample that received the placebo. In a post hoc analysis of adolescents (ages 12-17) who completed treatment, escitalopram significantly improved CDRS-R scores compared with the group that received the placebo. Headache and abdominal pain were the only adverse effects in just under 10 percent of the children who received escitalopram. Potential suicide-related events were observed in one member of the treatment group and in two members of the placebo group. There were no completed suicides. Although there were no significant differences between the treatment and placebo groups in the total sample, the data suggested that escitalopram might have beneficial effects in adolescent patients. Escitalopram was apparently well-tolerated in the treatment group. The study involved patients ages 6-17 who had major depressive disorder. They were randomized to receive 8 weeks of double-blind, flexibly dosed treatment with escitalopram. The 131 members of the treatment group received 10-20 mg of the medicine each day. The control group (n=133) received a nonmedicinal pill. The randomization of the two groups was not stratified by age. The primary measure of the drug's effectiveness was the mean change from baseline to endpoint in scores on the CDRS-R. 4 tables, 3 figures, and 27 references