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News Release

For immediate use

Nov. 15, 2006 -- No. 542

UNC to lead national study
of schizophrenia drug side effects

CHAPEL HILL – Drugs commonly used to treat schizophrenia often cause unwanted and dangerous side effects, such as weight gain and elevated cholesterol. But a new clinical trial led by the University of North Carolina at Chapel Hill’s School of Medicine will study strategies to reduce those problems while effectively treating the disorder.

UNC's Dr. Scott Stroup, an associate professor in the department of psychiatry, will serve as principal investigator. The study will be conducted through the Schizophrenia Trials Network, which was established by the National Institute of Mental Health, part of the National Institutes of Health, and is led by UNC. The network was developed from the infrastructure created for an NIMH-funded, UNC-led clinical trial known as CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness).

"People with schizophrenia are at much greater risk of heart disease than people in the general population," Stroup said. "For example, the CATIE trial identified that 42 percent of people with chronic schizophrenia have metabolic syndrome, an indicator of high risk.

"Switching medications is a common strategy but we don't have clear evidence that it is both safe and effective at lowering the risk of medical problems," Stroup said. "This study should help answer that question."

In the new study, researchers will enroll 300 patients with schizophrenia who are currently taking the drugs olanzapine, quetiapine or risperidone and are experiencing adverse metabolic side effects associated with an increased risk of cardiovascular disease. Half of these patients will be switched to aripiprazole, an antipsychotic medication made by Bristol-Myers Squibb and Otsuka Pharmaceutical Co. The rest will continue on their original medications. In addition, all of the patients will receive ongoing instruction on using diet and exercise to lower high cholesterol levels.

The study is sponsored by a new public-private partnership between the Foundation for the National Institutes of Health and Bristol-Myers Squibb Co., which provided $8 million to the foundation to fund the study.

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For more information about the CATIE trial, visit: http://www.catie.unc.edu/

School of Medicine contact: Stephanie Crayton, (919) 966-2860, scrayton@unch.unc.edu
News Services contact: Clinton Colmenares, (919) 843-1991, clinton_colmenares@unc.edu