There has been much controversy in recent years regarding the correlation between teenage suicide and the use of antidepressant drugs. At an FDA meeting reviewing this topic, the majority of clinical trials examined did not show that the drugs were effective in treating depression in children and adolescents.
In a recent study published in the September issue of the Journal of Clinical Pharmacology, Dr. Richard Malone, from the Department of Psychiatry at Drexel University College of Medicine and Philadelphia Health & Education Corporation, and colleagues suggest that the short duration of depressive symptoms in this age group makes it difficult to distinguish drug efficacy from placebo.
Using a naturalistic study design, the researchers advise using multiple assessments to establish a continuous baseline before randomizing patients to treatment, which would remove those who spontaneously recover in a very short period of time. In addition to having an impact on the accuracy of future clinical trials, this approach may help decrease the number of children who are exposed to unnecessary long-term drug therapy and possible side effects, since those who spontaneously recover quickly would not be started on drug therapy.
The article "Impersistence of Depression in Youth: Implications for Drug Study Design" can be accessed at no-charge for a limited time at The Journal of Clinical Pharmacology's web site at www.jclinpharm.org/cgi/reprint/46/9/1044.
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The Journal of Clinical Pharmacology