The National Institute of Mental Health initiated the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program to evaluate the effectiveness of antipsychotic drugs in typical settings and populations so that the study results will be maximally useful in routine clinical situations. The CATIE @entity161 trial blends features of efficacy studies and large, simple trials to create a pragmatic trial that will provide extensive information about antipsychotic drug effectiveness over at least 18 months. The protocol allows for subjects who receive a study drug that is not effective to receive subsequent treatments within the context of the study. Medication dosages are adjusted within a defined range according to clinical judgment. The primary outcome is all-cause treatment discontinuation because it represents an important clinical endpoint that reflects both clinician and @entity1 judgments about efficacy and tolerability. Secondary outcomes include symptoms, side effects, neurocognitive functioning, and cost-effectiveness. Approximately 50 clinical sites across the United States are seeking to enroll a total of 1,500 @entity1 with @entity161 . Phase 1 is a double-blinded randomized clinical trial comparing treatment with the second generation antipsychotics @entity1037 , @entity1089 , @entity1090 , and @entity1280 to @entity21886 , a midpotency first generation antipsychotic. If the initially assigned medication is not effective, subjects may choose one of the following phase 2 trials: (1) randomization to open-label @entity1088 or a double-blinded second generation drug that was available but not assigned in phase 1; or (2) double-blinded randomization to @entity1280 or another second generation drug that was available but not assigned in phase 1. If the phase 2 study drug is discontinued, subjects may enter phase 3, in which clinicians help subjects select an open-label treatment based on individuals' experiences in phases 1 and 2.

The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: XXXX trial design and protocol development.

@entity1 :: ('9606', 'Species') :: ['patient', 'persons'] @entity1088 :: ('MESH:D003024', 'Chemical') :: ['clozapine'] @entity21886 :: ('MESH:D010546', 'Chemical') :: ['perphenazine'] @entity1280 :: ('MESH:C092292', 'Chemical') :: ['ziprasidone'] @entity161 :: ('MESH:D012559', 'Disease') :: ['schizophrenia'] @entity1037 :: ('MESH:C076029', 'Chemical') :: ['olanzapine'] @entity1089 :: ('MESH:C069541', 'Chemical') :: ['quetiapine'] @entity1090 :: ('MESH:D018967', 'Chemical') :: ['risperidone']
@entity161 :: (MESH:D012559,Disease) :: ['schizophrenia']
