Study Findings Support Current Use
Researchers have found that an antidepressant used in children and adolescents for major depressive disorder (MDD) appears to be safe and effective, according to a new study reported in the Journal of the American Medical Association (JAMA).
The antidepressant Zoloft®, known generically as sertraline, is one of a class of drugs called selective serotonin reuptake inhibitors (SSRIs).
According to the report, 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.
Although the medications are commonly considered to be the best available pharmaceutical option for depressed children and teens, there have been very few studies done in this age group.
"There is a gap between our use of medications and the study of the medications," says Dr. Karen Dineen Wagner, lead author of the study. Dr. Wagner is director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston.
The antidepressant medications are usually studied first in adults and, once approved, are prescribed "off label" for children and teens.
"The problem is that I think less than 20 percent of medications are actually indicated [approved] for children, but a large percentage of them are used for children," says Dr. Eugenio Rothe, at the University of Miami School of Medicine and director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital.
"You can justify pediatric use if the medication has been proven to be effective in adults and you dose it according to the milligram per weight that's available for children," Dr. Rothe says.
The reason for this dearth of research is that it is very difficult to get approval for studies of antidepressants involving children. Institutional review boards of major institutions are often reluctant to approve them, and parents are often hesitant to involve their children, Dr. Rothe explains.
Depression Recognized More Frequently
However, the use of prescription antidepressants in children has skyrocketed during the last 10 to 15 years.
"The numbers vary a little, but the order of magnitude of increases in that period of time is something of the order of six to 10 times," says Dr. Christopher Varley, author of an accompanying editorial in JAMA and professor of child and adolescent psychiatry at the University of Washington School of Medicine in Seattle.
The current study represents something of a breakthrough, especially given that it is the largest psychopharmacological study of MDD in children and teens that showed a positive result.
The researchers looked at 376 children, ages 6 to 17, with MDD. In all, 53 hospitals, general practice, and academic centers in five countries were involved. The children were randomly assigned to receive either Zoloft® or a placebo (inactive substance) for 10 weeks. Changes in their depression were measured by the Children's Depression Rating Scale-Revised.
At the end of the 10-week study, 69 percent of the children on Zoloft® showed improvement, compared to 59 percent in the placebo group.
"By about three weeks, children in the medication group started to have more significant improvement than those in the placebo group, and these children had been ill for long periods of time," Dr. Wagner says. "The average length of illness was about two years."
Experts Say New Findings May Help Children
Says Dr. Varley: "It shows that kids got better compared to a placebo, but it wasn't like night and day. It didn't knock your socks off, but it was there. It's absolutely a good thing."
Dr. Rothe says, "Every time one of these studies comes across with conclusive research findings, it's one more hurdle that we've crossed because it's very difficult to help children with the present regulations. We've been using Zoloft® for a long time, and this just validates the situation."
The new study was funded by Pfizer, which makes Zoloft®.
Always consult your child's physician for more information.
Online Resources
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American Academy of Child and Adolescent Psychiatry
American Academy of Pediatrics
Centers for Disease Control and Prevention (CDC)
National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
National Library of Medicine, at NIH
