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Stephen Crystal Leads Multi-University Consortium to Study Use, Safety, and Effectiveness of Antipsychotic Medications

Under a $2.5 million award from the Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA), researchers at the Institute for Health with partners at Harvard Medical School/Brigham and Women’s Hospital, Vanderbilt University; and Columbia University, will conduct major studies of the use, safety, and effectiveness of antipsychotic medications. The newer “antipsychotic” medications are used increasingly in clinically diverse subpopulations of patients, but significant issues of safety and effectiveness remain to be addressed. These medications are prescribed for growing numbers of children and adolescents with behavioral disorders such as aggression, and for many elderly persons with behavioral symptoms of dementia, as well as for populations more traditionally treated with antipsychotic medications such as persons with schizophrenia. Antipsychotic medications represent the single most costly class of drugs for Medicaid programs and are received, for example, by 31% of nursing home residents with dementia, despite an FDA black box warning of significantly increased mortality associated with use of this class of medication in this population.

Researchers will be led by Principal Investigator, Dr. Stephen Crystal, at the Institute’s Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes that was launched in 2005 through a seed money award from Rutgers University Academic Excellence Fund. Three major substudies comprise the award. The first focuses on outcomes in the institutionalized elderly to examine mortality, stroke, myocardial infarction, and other medical outcomes and functional outcomes including cognitive function and behavioral symptoms of dementia. The second substudy will examine medication outcomes for children and adolescents and will combine analyses of Medicaid claims, medical charts, and electronic medical record data in Tennessee with Rutgers based analyses of national Medicaid data. The third study will examine several population-wide safety issues across the age spectrum, including risks of pituitary tumors, diabetes, and outcomes for elderly with dementia who live in the community. Across these studies, propensity scoring, instrumental variables, and other advanced statistical techniques will be used to examine risks and benefits across subpopulations, drug classes, and individual medications.

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