MEDICATIONS: SERTRALINE EFFECTIVE IN TREATING CHILDREN AND ADOLESCENTS WITH MAJOR DEPRESSION

Aug. 25, 2003 — The antidepressant medication sertraline is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder (MDD), according to an article in the August 27 issue of The Journal of the American Medical Association (JAMA).

According to the article, up to 3 percent of children and 8 percent of adolescents have MDD. The lifetime likelihood of having depression for youths aged 15 to 18 years old has been estimated at 14 percent to 15 percent — rates comparable with those of adults. Selective serotonin reuptake inhibitors (SSRIs) are safe, effective and well tolerated by adults, but their safety and efficacy has not been well established in depressed children and adolescents. Karen Dineen Wagner, M.D., Ph.D., of University of Texas Medical Branch, Galveston, Texas, and colleagues studied the efficacy and safety of sertraline (an SSRI drug) compared with placebo on 376 children and adolescents with MDD aged 6 to 17 years old. The children and adolescents were participants in two multi-center randomized, double-blind, placebo-controlled trials conducted at 53 hospitals, general practice, and academic centers in the United States, India, Canada, Costa Rica and Mexico between December 1999 and May 2001. The results from these two trials were pooled for the current study. Participants were randomly assigned to take either a flexible dosage (50 to 200 milligram per day) of sertraline (n=189) or placebo (n=187) for 10 weeks. Changes in their depression (based on the Children's Depression Rating Scale — Revised [CDRS-R scores]) were used to evaluate the effects of the drug or placebo.

The researchers found that the children and adolescents assigned to the sertraline group experienced statistically significant greater improvements in their depression compared to participants taking placebo at week 10 of treatment. Based on CDRS-R scores, 69 percent of sertraline-treated patients compared with 59 percent of placebo treated patients were considered responders. Sertraline was generally well tolerated. Seventeen sertraline-treated patients (9 percent) and five placebo patients (3 percent) 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 MDD, with statistically greater improvement occurring as early as week three," the authors write. "... the results reported here support the conclusion that sertraline is an effective, safe and well tolerated short-term treatment for children and adolescents with MDD."

Editorial: Psychopharmacological Treatment of Major Depressive Disorder in Children and Adolescents

In an accompanying editorial, Christopher K. Varley, M.D., of the University of Washington School of Medicine, Seattle, writes, "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 finding 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." "... prudent practice in the treatment of depressive illnesses in children and adolescents must include careful attention to the decision to treat a child or adolescent with medication for MDD; clinical expertise with mental health assessment, consideration of varied treatment modes including cognitive behavioral or interpersonal psychotherapy, partnership with patients and their parents, and careful attention to symptom course, particularly emotional liability and the assessment of suicidal ideation in youth who are treated with antidepressant medications (specifically SSRIs, and more particularly, paroxetine)," writes Dr. Varley. "Current evidence continues to support the use of SSRIs, particularly fluoxetine and sertraline, in the treatment of MDD in children and adolescents," Dr. Varley concludes.