Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
To the Editor: Dr Wagner and colleagues1 presented the results of 2 randomized controlled
trials suggesting that sertraline is effective for treating MDD in children
and adolescents. I believe the authors' statement that their findings are
"clinically as well as statistically relevant" is premature.
First, it is unclear why 2 separate trials (introducing additional variability),
rather than 1 larger trial, were conducted. Second, the rationale for the
a priori decision to define response as a 40% decrease in depressive symptoms,
rather than the more commonly used 50% decrease in symptoms, is unclear. This
seems to create a bias for a favorable result for sertraline. Third, the authors
used the last-observation-carried-forward method rather than a more conservative
analysis considering noncompleters as nonresponders. Nonetheless, sertraline
barely achieved a statistically significant improvement over placebo. It is
unlikely that statistically significant results would have been observed with
a more conservative analysis and a higher (and more usual) threshold for response.
Price D. Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder. JAMA. 2004;291(1):40. doi:10.1001/jama.291.1.40-b