CHAPEL HILL, N.C. - The University of North Carolina at Chapel Hill has won a $42.1 million federal contract to determine the effectiveness and safety of a new class of anti-psychotic drugs for treating people with schizophrenia and those with psychotic and disruptive behaviors associated with Alzheimer's disease.
The contract, announced today by the National Institute of Mental Health (NIMH) in Bethesda, Md., is the largest ever awarded by the federal agency. It places the university in charge of a multi-center, five-year effort aimed at definitively determining the value of the new class of atypical anti-psychotic drugs represented by clozapine, risperidone, olanzapine and quetiapine.
"This research will make an unparalleled contribution to defining the clinical role of the new anti-psychotics," said Dr. Steven E. Hyman, director of the NIMH. "It will provide reliable data on the efficacy of these atypical medications in relieving psychotic symptoms of schizophrenia and Alzheimer's disease, and will gauge their effectiveness in terms of broader outcomes - such as adherence to treatment, ability to work, social functioning and quality of life."
Now on the market, these drugs are proven effective in carefully controlled clinical studies typically co-sponsored by drug companies. The drugs differ from other anti-psychotic agents in that they act on multiple cell receptor sites in the brain, including receptors for dopamine, serotonin and norepinephrine, instead of just dopamine.
However, the new drugs cost more than 10 times that of the old medications and questions remain about their effectiveness in the real world and whether they are worth the higher price.
"The NIMH wants to get definitive and objective results in terms of their
effectiveness, results of significant magnitude in real world settings that can
inform public health policy," said Dr. Jeffrey A. Lieberman, professor of
psychiatry, pharmacology and radiology at UNC-CH
Contact: Lynn Wooten
University of North Carolina School of Medicine