Services Effectiveness Research Program (SERP)

Duke University School of Medicine
Department of Psychiatry and Behavioral Sciences

Current and Recent Projects

Title: Comparative Effectiveness of Antipsychotic Medications in Patients with Schizophrenia (CATIE): Risk for Violence and Substance Abuse

Sponsor: Eli Lilly and Company

Principal Investigator(s): Jeffrey Swanson, PhD; Marvin Swartz, MD

SERP Investigators & Collaborators: Richard Van Dorn, PhD; Ryan Wagner, PhD

Project Description: The advent of newer “atypical” antipsychotic medications has raised hope that treatments for schizophrenia will be more effective and better tolerated. However, definitive evidence has not yet been provided that these medications can reduce morbidity and hospital use and improve community functioning, as compared to the conventional antipsychotic or neuroleptic drugs. Further, only a few studies have compared the newer atypicals one against another. Phase 1 of this study will compare atypical antipsychotics with a conventional antipsychotic and with each other. Patients who fail (i.e., have insufficient response or intolerable side effects) in Phase 1, may go into Phase 2, and failing Phase 2 may go into Phase 3. Each change will assure that patient is tried on another medication. Outcome measures will include measures of efficacy, safety, quality of life, cognition and use of psychiatric services. A broad range of patients with the chronic and recurrent forms of schizophrenia will be recruited at sites representing an array of clinical settings in order to generate representative, generalizable and practically relevant information. This is a multi-center program funded by a contract with NIMH. The Principal Investigator for this program is Dr. Jeffrey Lieberman at the University of North Carolina at Chapel Hill . Dr. McEvoy is Co-Principal Investigator of the program and Principal Investigator at this site for this clinical sub-contract.

This is a randomized, multi-center controlled trial of up to 1600 patients at 50 sites (72 at this site (combined in and outpatient) with schizophrenia, involving the following medications: perphenazine, clozapine, olanzapine, quetiapine, risperidone and ziprasidone. All of these are FDA approved drugs for the treatment of schizophrenia. Patients will be followed for up to 23 months. There are 2 double-blind parallel treatment phases (1 & 2) followed by an open-label phase 3. All treatments will be double blinded in treatment Phases 1 and 2 except for clozapine in Phase 2 (because of the need for weekly blood draws). A special consent is attached for those assigned to clozapine.