$42.1 million contract awarded for drug study

The University has been awarded 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 as well as psychotic and disruptive behaviors linked with Alzheimer's disease.

The contract, announced Oct. 14, is the largest ever awarded by the National Institute of Mental Health (NIMH) in Bethesda, Md. Carolina will lead a five-year effort at multiple sites to decide the value of the new group 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 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 have 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.

The new drugs cost more than 10 times that of the old medications and questions remain about their effectiveness and if 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 Jeffrey A. Lieberman, professor of psychiatry, pharmacology and radiology at the School of Medicine.

Lieberman and C. E. Davis, professor and chair of biostatistics at the School of Public Health, are the project's co-principal investigators. Over the next five years, they and colleagues will enroll 1,000 patients with schizophrenia and 400 to 500 Alzheimer's patients. The terms of the NIMH contract include an option for expansion studies and a five-year extension.

Federal grants are outright forms of financial assistance for university-derived research ideas. Contracts, on the other hand, stem from federal research needs and are awarded after universities competitively bid through requests for proposal. Lieberman said several key factors contributed to Carolina's successful bid.

"The University and the psychiatry department have a long tradition of research in the pathological basis of mental illness and the development of therapeutic strategies," he said.

The University also has experience conducting similar trials, including serving as the lead university for ongoing studies at multiple sites on atypical anti-psychotic drugs in North America and Europe.

"There is a pre-existing research history here with an infrastructure," he said. "The School of Public Health has a lot of experience acting as a coordinating center for large-scale, multi-center trials. That expertise helped make us very competitive for the award."

In the new work, Carolina will subcontract to other universities to help coordinate the trials, involving faculty from Duke and Yale universities as well as the universities of Southern California and Rochester. Quintiles Inc., based in the Research Triangle Park, will help manage the study sites.

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