BETHESDA, Md., Nov. 14--The Foundation for the National Institutes of Health (FNIH) and the National Institutes of Health (NIH) today announced the launch of a public-private partnership to conduct a clinical trial with 300 patients with schizophrenia to determine the effect of aripiprazole vs continued treatment with olanzapine, quetiapine or risperidone on metabolic changes, including weight gain and non-HDL cholesterol, that are common side effects of many schizophrenia treatments. These metabolic changes are associated with a significantly increased risk of cardiovascular disease.

The Bristol-Myers Squibb Company is providing $8 million to the Foundation to fund an independent, peer-reviewed study designed by researchers at the University of North Carolina at Chapel Hill (UNC), in collaboration with the National Institute of Mental Health (NIMH), part of the NIH. The study, which will also be conducted by the UNC investigators, will compare the effectiveness of an antipsychotic medication with a low risk of metabolic side effects to medications associated with a high risk of occurrence.

The study will be conducted through the Schizophrenia Trials Network (STN), a new resource established by NIMH for investigators in the field of schizophrenia research. The network, led by UNC and made up of specially-trained teams of investigators at 30 clinics across the United States, was developed from the infrastructure created for the NIMH-funded trial known as CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness). This network of investigators and clinical facilities was formed to carry out complex, multi-site randomized clinical trials in community settings to explore longer-term treatments of schizophrenia and related disorders.

The study will allow the researchers to evaluate the metabolic side effects that pose serious public health concerns for the more than 2.4 million Americans with schizophrenia and schizoaffective disorder. Researchers will enroll 300 patients with schizophrenia or schizoaffective disorder who are currently taking olanzapine, quetiapine, or risperidone and for whom a medication change may be indicated because of adverse metabolic changes associated with an increased risk of cardiovascular disease. Half of the participants will be switched to aripiprazole, a prescription antipsychotic medication made by Bristol-Myers Squibb and Otsuka Pharmaceutical Company. The remainder of the participants will continue with their original treatment. All individuals in the study will receive a structured program focusing on diet and exercise as a means to reduce high cholesterol associated with cardiovascular disease.

“This study will help us learn how best to address medical problems that were clearly identified in the original CATIE schizophrenia study,” said Scott Stroup, M.D., associate professor in the department of psychiatry of the UNC School of Medicine. “We know that switching medications is a common strategy but we don’t have clear evidence that it is both safe and effective at lowering risk of medical problems. We are grateful to FNIH for coordinating the efforts that will allow us to conduct this study independently.”

The initiative is managed and coordinated by FNIH in collaboration with NIMH. FNIH will convene and staff an executive committee composed of NIMH and outside experts to oversee the scientific progress of the study. The University of North Carolina, which led the CATIE trial, received a multi-year grant from FNIH to conduct the study. FNIH coordinated and managed independent scientific peer review of the application in consultation with NIMH.

“This project will be the first such collaboration to take advantage of the unique clinical research network now in place to help us answer questions that are important for improving the lives of people with schizophrenia,” said NIMH Director Thomas Insel, M.D. "FNIH is pleased to participate in this public-private partnership which demonstrates the capability and value that FNIH brings to addressing some of our most important health problems," added Foundation for NIH Chairman Charles A. Sanders, M.D.

Bristol-Myers Squibb was initially consulted regarding the study concept and design but had no influence over the final peer-reviewed protocol nor will it have any access to – or control over –the data generated through the study or the analysis or reporting of the results.

“Bristol-Myers Squibb is committed to helping the scientific community evaluate treatment alternatives to determine whether there are options that will help people living with schizophrenia to receive the most effective care while decreasing the potential for other treatment-related serious medical problems,” said Brian Daniels, M.D., senior vice president, Global Clinical Development, Bristol-Myers Squibb Company. “We are pleased to support the FNIH through this important public-private partnership.”

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The National Institutes of Health -- "The Nation's Medical Research Agency" -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH Web site, http://www.nimh.nih.gov.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. For more information, visit http://www.bms.com.

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Schizophrenia Metabolic Initiative Executive Committee

William T. Carpenter Jr., M.D., Chair
Professor of Psychiatry and Pharmacology
University of Maryland School of Medicine
Director
Maryland Psychiatric Research Center

Dr. Robert Buchanan, MD

University of Maryland School of Medicine
Maryland Psychiatric Research Center

John Hsiao, MD

Chief, Adult Psychopharmacology Program

Division of Services and Intervention Research

National Institute of Mental Health

David Shore, MD

Associate Director, Clinical Research, Office of the Director

Acting Director, Division of Services and Intervention Research

National Institute of Mental Health

Wim Swyzen, MD
Vice President, Neuroscience Medical Strategy
US Pharmaceuticals Medical Affairs
Bristol-Myers Squibb

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