According to the article, up to 3 percent of children and 8 percent of adolescents are affected by the disorder. Although the selective serotonin reuptake inhibitors have been proven to be safe, effective and well tolerated by adults, their safety and efficacy has not been well established in depressed children and adolescents.

Karen Dineen Wagner, M.D., Ph.D., and her American colleagues studied the efficacy and safety of sertraline compared with placebo among 376 patients ages 6 to 17 years diagnosed with major depressive disorder. The children and adolescents were participants in 2 different multi-center randomized, double-blind, placebo-controlled trials conducted at 53 centers in the United States, India, Canada, Costa Rica, and Mexico between December 1999 and May 2001. The results from the trials were pooled for the current study.

Half of the participants were randomized to a flexible dosage (50 to 200 mg daily) of sertraline for 10 weeks, while the other half received an oral placebo. Changes in depression based on scores from the Children's Depression Rating Scale - Revised (abbreviated as CDRS-R) were used to evaluate drug and placebo effects.

At week 10 of treatment, the children and adolescents in the sertraline group experienced statistically significantly greater improvements in depression compared with the patients in the placebo group. Based on the depression scale scores, 69 percent of sertraline-treated patients were considered responders compared with 59 percent of placebo-treated patients. Sertraline was generally well tolerated. A total of 17 patients (9 percent) in the sertraline group and 5 patients (3 percent) in the placebo group discontinued the study because of adverse events including diarrhea, vomiting, anorexia, and agitation.

"In the trials reported here, sertraline was found to be more effective than placebo for the treatment of pediatric major depressive disorder, with statistically greater improvement occurring as early as week 3," the authors wrote. "... the results reported here support the conclusion that sertraline is an effective, safe and well tolerated short-term treatment for children and adolescents with major depressive disorder."

In an accompanying editorial, Christopher K. Varley, M.D., wrote, "In the current study by Wagner et al, 69 percent of the patients receiving sertraline were considered responders compared with 59 percent of those receiving placebo, a difference of only 10 percent. These findings suggest that children may be more responsive than adults to nonspecific measures of support that are included in the placebo response, possibly because children and adolescents are on a more dependent and reactive developmental state."

"Current evidence continues to support the use of selective serotonin reuptake inhibitors, particularly fluoxetine and sertraline, in the treatment of major depressive disorder in children and adolescents," he concluded.