STAR*D: A Tale and Trail of Bias

The 35-million-dollar Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study is the largest antidepressant effectiveness study ever conducted. STAR*D enrolled 4,041 depressed patients and provided them with exemplary free acute and continuing antidepressant care to maximize their likelihood of achieving and maintaining remission. Patients who failed to get adequate relief from their first antidepressant were provided with up to three additional trials of pharmacologically distinct treatments. This article identifies numerous instances of apparent bias in the conduct and reporting of outcomes from this study. In contrast to STAR*D's report of positive findings supporting antidepressants' effectiveness, only 108 of its 4,041 patients (2.7%) had an acute-care remission, and during the 12 months of continuing care, these patients neither relapsed nor dropped out. This article also discusses the roles of the American Journal of Psychiatry (AJP) and the National Institute of Mental Health (NIMH) in promoting the biased reporting of STAR*D's results.