Introduction. Evaluating the Evidence: Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and Beyond

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Placebo-controlled efficacy trials conducted for U. S. Food and Drug Administration registration and approval purposes are an essential component of evidencebased pharmacotherapy. However, these efficacy studies have several shortcomings, including a very short duration (3–6 weeks) and rigid inclusion criteria that exclude subjects with a history of treatment resistance, coexisting medical illnesses, or comorbid substance use. Thus, the outcomes in real-world patients often fall short of the outcomes in controlled clinical trials.​

J Clin Psychiatry 2007;68(suppl 1):3-4