NEWS

UNC expands historic schizophrenia study to incorporate newest antipsychotic drug

By SHERYL W. MCKELVEY
UNC Department of Psychiatry

CHAPEL HILL -- Researchers at the University of North Carolina at Chapel Hill School of Medicine are expanding nationwide clinical trials of antipsychotic medications to include the latest schizophrenia drug to receive approval for market use from the U.S. Food and Drug Administration.

Aripiprazole (Abilify) was added to ensure that study results are relevant to current clinical practices, said Dr. Jeffrey A. Lieberman, principal investigator for the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE, project and professor of psychiatry, pharmacology and radiology at UNC’s School of Medicine.

"The objective of the CATIE trials is to determine the relative effectiveness of antipsychotic medications, which have never before been extensively compared in the same trial," he said. "It’s important to add newly available medications like aripiprazole so that the research is comprehensive. Ultimately, CATIE findings about these medications will enable health-care providers to make more informed and cost-effective choices about treatment."

The National Institute of Mental Health supports the CATIE project, led by UNC’s departments of psychiatry and biostatistics. CATIE is the first large-scale comparison study of its kind. UNC was tapped for the project in 1999 and began enrolling participants in December 2000. Currently, 90 clinical sites in 27 states have enrolled more than 1,300 patients; completion of the trials is set for July 2005.

The CATIE trials examine which of the new generation of antipsychotic drugs are best for treating patients with schizophrenia and disruptive behaviors associated with Alzheimer’s disease. Aripiprazole will be added to the list of antipsychotics being studied in the schizophrenia trial.

CATIE was originally designed to examine the effectiveness of the various classes of antipsychotic drugs represented by clozapine, risperidone, olanzapine, quetiapine and perphenazine. Ziprasidone, which received FDA approval in 2001, was added to the schizophrenia trials in January 2002.

Unlike first-generation antipsychotic agents, which act primarily on the brain’s dopamine system, the newer drugs being studied by CATIE also act on serotonin and other neurotransmitter systems. They also cost at least 10 times more than the first-generation antipsychotics. Project results will help determine if they are effective and whether they are worth the higher price.

"The development of these new drugs has been like going from a one-size-fits-all Model T to today’s many model options," said Dr. John Hsiao, National Institute of Mental Health project officer for CATIE. "The advancement is tremendous, but with so many new treatment options, we don’t know which drug to use when. CATIE will show the effects of each medication and help clinicians choose which treatment is best for each patient."

The study is a multi-institutional effort led by UNC and managed by Quintiles Inc. of Research Triangle Park. UNC works with other academic centers to coordinate the trials, involving faculty from Duke University, the University of Southern California, Yale University and the University of Rochester.

Lieberman and Dr. C.E. Davis, professor and chair of biostatistics at the UNC School of Public Health, are the project’s co-principal investigators. Dr. Lon Schneider, professor of psychiatry, neurology and gerontology at USC; and Dr. Pierre Tariot, professor of psychiatry and neurology at the University of Rochester, direct the Alzheimer’s disease trials.

Key UNC investigators are Drs. Scott Stroup and Diana Perkins. Other investigators leading the trial are Drs. Joseph McEvoy, Marvin Swartz and Richard Keefe at Duke; and Dr. Robert Rosenheck at Yale.

N.C. sites include UNC, Duke, John Umstead Hospital in Butner, Dorothea Dix Hospital in Raleigh, Wake Forest University School of Medicine in Winston-Salem and the Behavioral Health Center in Charlotte.

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URL note: For a full list of trial sites, click on http://www.catie.unc.edu/schizophrenia/sp_clinicalsites.htm. For additional information on the CATIE project, click on www.catie.unc.edu.

Note: Contact Lieberman at (919) 966-8990 or jlieberman@med.unc.edu.

Department of psychiatry contact: Crystal Hinson, (919) 966-9115 or chinson@med.unc.edu
News Services contact: Deb Saine, (919) 962-8415