A new study published in the New England Journal of Medicine supports the effectiveness of combined medication and cognitive-behavioral therapy for children with anxiety. The study, sponsored by the National Institutes of Health, utilized sertraline, which is sold under Pfizer’s brand name Zoloft, to treat a majority of 488 kids, aged 7-17. Some of the subjects also received CBT, and some got CBT alone. The rest were given a placebo.
The results were quite convincing. While just under 60% showed improvement with either medications or CBT alone, over 80% improved with combined therapy. Under one quarter showed improvement with a placebo alone.
Zoloft is approved for treating adults with depression or anxiety, but only for treating obsessive-compulsive disorder in children. However, it is often prescribed “off-label” for use with children experiencing all kinds of anxiety disorders, such as separation anxiety, generalized anxiety, and phobias.
The U.S. Food and Drug Administration has recognized a risk of increased suicidal ideation in children, particularly adolescents, who begin taking certain anti-depressants, and in 2004 ordered strict warning labels on such medications. Since then, teen suicides have risen slightly, rather than decreasing. In the new NIH study none of the children attempted suicide, and researchers said they found no significant increase in suicidal thoughts among those taking sertraline.
The new study will likely provide welcomed information for a currently on-going congressional inquiry into ties between drug manufacturers and medical researchers, particularly those studying medications given to children.
The researchers in this new study, led by John Walkup, deputy director of Johns Hopkins’ Division of Child and Adolescent Psychiatry, said Pfizer did provide free samples of Zoloft to be administered, but wasn’t involved in other aspects of the study. The researchers did receive consulting fees from drug companies, including Pfizer, Eli Lilly, Jazz Pharmaceuticals, and GlaxoSmithKline.
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