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To the Editor: Dr Wagner and colleagues¹ compared sertraline with a placebo. The scientific and ethical justification of such an experimental design is questionable. Kupfer and Frank² recently discussed the pitfalls of placebo-controlled, multicenter, outpatient randomized clinical trials for the study of effectiveness of antidepressant medications. Kupfer and Frank acknowledged "the variability in placebo response from trial to trial" and stated that the placebo response "has increased significantly in recent years." Furthermore, because the authors excluded patients at risk of suicide, their sample may have comprised patients with only moderate depression. For these reasons, it is difficult to generalize these results to clinical practice.

Sertraline and other selective serotonin reuptake inhibitors may be effective and safe medications for both pediatric and adult patients, but only if selected, dosed, changed, and managed according to the individual characteristics and responsiveness of patients with severe MDD. Such clinical practice may not require a . . . [Full Text of this Article]

Antal E. Solyom, MD, PhD, MA
Center for Biomedical Ethics
University of Virginia
Charlottesville

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