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Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial

Overview This trial was conducted in the United States and enrolled 1493 patients with chronic schizophrenia, randomizing them to either a second-generation (i.e., atypical) antipsychotic (olanzapine, quetiapine, risperidone, or ziprasidone) or medium-potency first-generation drug, perphenazine. The trial was run over 57 sites between 2001-2004 and the sample size had 76% power to detect 12% differences in discontinuation rates < /ref name 1>. The trial was structured as to mimic clinical practice as best as possible with certain study design characteristics: there were broad inclusion criteria, patient drug preference was incorporated and therefore was not a double-blinded trial as both the clinicians and patients knew which antipsychotics were being prescribed. Notably, the primary outcome being measured was discontinuation of the drug for any reason rather than symptom improvement. The trial was structured this way to define "drug failure" in as a broad and simple categorical variable.

Lewis, Shon and Jeffrey Lieberman. CATIE and CUtLass: can we handle the truth? The British Journal of Psychiatry. Feb 2008, 192 (3) 161-163; DOI: 10.1192/bjp.bp.107.03218