UNC expands national clinical trials of schizophrenia and Alzheim...( UNC-Chapel Hill receives additional $...),Health

CHAPEL HILL - The University of North Carolina's Department of Psychiatry is expanding its large-scale effectiveness trials of anti-psychotic medications for schizophrenia and behavioral problems in Alzheimer's disease to include a newly-approved drug. The National Institute of Mental Health (NIMH) is providing an additional $18 million to the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project, bringing the total contract to $60 million.

The two CATIE trials are examining which of the new generation of anti-psychotic drugs are best for patients with schizophrenia and disruptive behaviors associated with Alzheimer's disease. Completion of the trials is set for September 2004, but terms of the NIMH contract include an option for a five-year extension and expansion studies.

The study was originally designed to examine the effectiveness of the various classes of anti-psychotic drugs represented by clozapine, risperidone, olanzapine, quetiapine and perphenazine. Now ziprasidone, which received Food and Drug Administration (FDA) approval last February, will be added to the schizophrenia trial.

Once the FDA deemed ziprasidone effective in treating psychosis in schizophrenia, CATIE investigators proposed adding it to enhance the scientific value and clinical relevance of the study's results.

"The major objective of the CATIE trials is to determine the most effective treatments in real-world settings, so it's important that we examine new medications as they become available to patients," explained Dr. Jeffrey A. Lieberman, CATIE's principal investigator. Lieberman is a professor of psychiatry, pharmacology and radiology at the UNC-Chapel Hill School of Medicine.

"Unlike smaller studies of the past, the CATIE trials embrace a broader public health model of intervent
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Contact: Sheryl McKelvey
sheryl_mckelvey@med.unc.edu
919-843-3784
University of North Carolina School of Medicine
28-Jan-2002