OCTOBER 31, 2008
Therapy, Drugs Ease Children's Anxiety
Researchers Find Combination of Treatments Is More Effective Than Either One Alone
The new research is sure to add to the already fierce debate about giving antidepressants to children.
In 2004, the U.S. Food and Drug Administration ordered drug makers to put a strong "black-box" warning on antidepressant labels, saying the medications can lead to suicidal thoughts in children. The warning led many doctors to shy away from prescribing the drugs. Since then, teen suicides have risen, leading some researchers to say the increase could be associated with lower use of antidepressants.
In the new study, released Thursday by the New England Journal of Medicine, none of the children committed suicide, and researchers said they found no significant increase in suicidal thoughts among those taking an antidepressant. The study was government funded and examined 488 children, ages 7 to 17. Some received sertraline, an antidepressant sold both in generic form and under the brand name Zoloft by Pfizer Inc.
For adults, the FDA has approved the drug to treat conditions including depression and anxiety. For children, it is approved only to treat obsessive-compulsive disorder, a kind of anxiety disorder. But psychiatrists widely use sertraline "off label" to treat depression and a range of anxiety disorders in children. The children in the study, whose average age was about 11, had a primary diagnosis of separation anxiety, generalized anxiety disorder or social phobia.
Some children in the study also underwent cognitive behavioral therapy, or CBT. Unlike conventional psychotherapy, CBT is often short term and focused on helping patients develop specific strategies to change negative thought processes. Of patients receiving both sertraline and CBT, 80.7% showed improvement, compared to 59.7% for CBT alone, 54.9% for sertraline alone and 23.7% given a placebo, the study found.
Louis Kraus, chief of child and adolescent psychiatry at Rush University Medical Center in Chicago, who wasn't involved in the study, called the effectiveness of combination treatment "incredible." But he said that patients are facing a severe shortage both of child psychiatrists and professionals trained in CBT, a situation that could make it difficult for children to get the treatment they need. Studies have estimated that 10% to 20% of children suffer from anxiety disorders.
The new study comes amid a congressional inquiry into financial ties between drug companies and medical researchers, including those studying psychiatric drugs given to children.
The National Institute of Mental Health, part of the federal government's National Institutes of Health, funded the study. Pfizer provided free sertraline and matching placebo. The researchers, led by John Walkup, deputy director of Johns Hopkins' Division of Child and Adolescent Psychiatry, said Pfizer wasn't involved in other aspects of the study. The researchers listed on the study reported receiving a variety of payments from drug companies, including Pfizer. Dr. Walkup reported consulting fees from Eli Lilly & Co., Jazz Pharmaceuticals Inc. and GlaxoSmithKline PLC, all of which market antidepressants.
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