The antidepressant Zoloft appears to be safe and effective for children and adolescents suffering from major depressive disorder, a new study finds.
Zoloft, known generically as sertraline, is one of a class of drugs called selective serotonin reuptake inhibitors (SSRIs). Although the drugs are commonly considered to be the best available pharmaceutical option for depressed children and teens, there is relatively little hard data for this age group.
A gap between use and study of drugs
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 that appears in the Aug. 27 issue of the Journal of the American Medical Association. She is also a professor of psychiatry and director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston.
The 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, associate professor of psychiatry at the University of Miami School of Medicine and director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital, also in Miami.
You can justify paediatric 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, Rothe says.
Difficult to get approval
The reason for this dearth of research is that it's 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, Rothe explains.
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 the journal and professor of child and adolescent psychiatry at the University of Washington School of Medicine in Seattle.
New study is a breakthrough
The current study represents something of a breakthrough, especially given that it is the largest psychopharmacological study of major depressive disorder (MDD) in children and teens that showed a positive result. The trial was funded by Pfizer, which makes Zoloft.
The study comes after the US Food and Drug Administration announced in June that it was reviewing reports that children under the age of 18 who took paroxetine (marketed as Aropax-20 in South Africa) had an increased risk of suicidal thoughts and suicide attempts.
While the FDA recommended that paroxetine, which is also an SSRI, not be prescribed to new patients, it also emphasised that those children taking the drug should not suddenly discontinue its use.
Also in June, the United Kingdom's Department of Health issued a somewhat stronger statement, saying paroxetine must not be used to treat people under the age of 18.
Some experts believe the FDA's announcement may have been excessive. At the very least, it points to the need for more trials of antidepressants in children and adolescents, says Rothe.
The Zoloft study
For the Zoloft study, the authors 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 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.
The improvements also came relatively swiftly. 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. The average length of illness was about two years, Wagner says.
One more hurdle crossed
Says 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.
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. - (HealthDayNews)
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