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The new research on Zoloft may buttress the views of psychiatrists who say the risks of taking the drugs are smaller than the risks of not taking them. David Shaffer, chief of Child and Adolescent Psychiatry at Columbia University in New York, believes that a drop in the suicide rate among U.S. adolescents likely stems from the advent just over a decade ago of SSRI medicines. Dr. Shaffer has no financial affiliations with any antidepressant maker.
As many as a quarter of adolescents in the U.S. have entertained thoughts of suicide at least once, estimates Joseph Biederman, psychiatry professor at Harvard Medical School and Massachusetts General Hospital. The JAMA study noted that half of adolescents with major depression attempt suicide at some point in their lives. British regulators "have taken a severe position," says Dr. Biederman, who gets research support and is a speaker for Lilly and Pfizer. "I would be very reassuring to parents who are considering the use of medication."
In the 10-week Zoloft trials, involving 376 kids from six to 17 years old, 69% of the patients taking Zoloft saw significant improvement, compared with 59% of those taking inactive pills. For a treatment to be considered successful, the patients had to see at least a 40% improvement in the symptoms of major depression. The research was sponsored by Zoloft maker Pfizer Inc.
Why the high placebo response? "Although it's an inactive pill, there are a lot of interventions that actually take place during the course of the study," says Karen Dineen Wagner, the principal author and director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston. The patients, for instance, have frequent meetings with psychiatrists and research staff, none of whom know which patient is on the drug and which is on the placebo. Kids may respond more than adults to the added attention.
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Zoloft was more successful than the placebo in treating irritability,
low self-esteem, excessive weeping, listless speech and lethargic behavior.
Two patients taking Zoloft and two taking placebos attempted suicide during
the research, and there wasn't any statistically significant difference in
suicidal thinking between the groups. At least twice as many Zoloft takers
reported vomiting and other physical effects. Pfizer says it has received
an FDA letter that likely will allow the company to add the
pediatric-safety information from the trials to Zoloft's label, but it
still has to work out the wording with the FDA.
While most kids go through rough patches, major depression is a debilitating illness. Kids with the ailment often can't get out of bed in the morning. They sometimes withdraw from friends and family, get unusually irritable and experience a change in sleeping patterns and appetite. They lose interest in activities that once were fun and can have feelings of low self-esteem and hopelessness. Grades in school often drop.
Doctors have long noted that the risk of suicide can increase in the early days of depression treatment. Some patients who previously were inert from depression gain energy and are briefly more prone to admit they have suicidal thinking or act on it.
Before starting any child or adolescent on antidepressants, John Walkup, an associate professor in the Division of Child and Adolescent Psychiatry at Johns Hopkins Children's Center in Baltimore, raises the issue of suicide with kids and their parents, noting that the medicines "activate and energize." "Sometimes they do it in a positive way that's part of the treatment for depression, and sometimes they do it in a negative way, where they agitate," says Dr. Walkup, who has received research grants and speaking fees from the makers of antidepressants.
Dr. Walkup still feels the benefits outweigh the risks. He tells patients and their parents he's going to watch carefully for signs of trouble. If a patient has suicidal thoughts, he says, "we manage it."
One mother in Oldwick, N.J., whose sons have been patients of Dr. Shaffer at Columbia, says she was concerned about the suicide issue but ultimately opted for antidepressants. When her oldest son began taking Prozac at age 15, she says, "the result was striking. For the first time he had normal relationships with other people." Later, she said, he had good results with Paxil.
To John March, chief of child psychiatry at Duke University, the wisest approach is to start with cognitive behavioral therapy, and then, if that doesn't work sufficiently on its own, to add a medication. Dr. March, who has received research grants from Lilly and research and consulting funds from Pfizer, adds: "These medicines are not a panacea, and will not, on average, carry kids to remission."
Source: WSJ
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