Zoloft
Found Safe, Effective in Children
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
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
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