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Commentary: Methodologies to Avoid the Enrollment of Ineligible Patients in Clinical Trials

J Clin Psychiatry 2012;73(11):1426-1427

The author comments on the need for improving clinical trial methodology to reduce failure of clinical trials with psychotropic agents. The commentary looks at companion articles that illustrate the problem, the first of which describes a failed study of adjunctive ziprasidone combined with lithium or divalproex compared to lithium or divalproex monotherapy, and the second addresses the influence of protocol-specific eligibility criteria on signal detection in the failed study.