NEW BRUNSWICK, N.J. – Rutgers, The State University of New Jersey, has received a $2.3 million grant from the federal Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA) to lead a major study of use, safety and effectiveness of antipsychotic medications.
These medications have come to be widely used in a clinically diverse population, including many children and adolescents with such behavioral disorders as aggression and elderly persons with symptoms of dementia, as well as adults with schizophrenia and other serious mental illnesses. Use of antipsychotic medications has increased and broadened with the advent of newer, "atypical" antipsychotic drugs perceived as safer than older drugs, according to principal investigator Professor Stephen Crystal of Rutgers' Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes.
However, as the AHRQ and FDA noted in their request for applications, evidence remains incomplete on safety and effectiveness in various subpopulations of patients treated with these medications, Crystal said. Areas of particular concern include use in youth and in the elderly. Crystal, whose center is a unit of the Institute for Health, Health Care Policy and Aging Research (IHHCPAR), said that Harvard Medical School/Brigham and Women's Hospital, Vanderbilt University and Columbia University are partners in the Rutgers-led consortium.
Investigative teams will conduct three substudies using large, linked health care datasets. The first will focus on outcomes in the institutionalized elderly to examine medical outcomes, such as mortality, stroke, myocardial infarction, as well as cognitive function and behavioral symptoms of dementia. The Rutgers team will expand a research dataset developed through the AHRQ-funded Center for Education and Research on Mental Health Therapeutics, to support analyses by Harvard and Rutgers investigators on medication outcomes on several million nursing home residents across the nation.
A second substudy, examining medication outcomes for children and adolescents, will combine analyses of Medicaid claims, medical charts and electronic medical record data in Tennessee (led by Vanderbilt investigators) with Rutgers-based analyses of national Medicaid data. The third substudy will examine several populationwide safety issues across the age spectrum, including risks of pituitary tumors, diabetes and outcomes for elderly with dementia who live in the community.
"The initiative by AHRQ and the FDA to fund this study represents a significant step forward in helping to provide better information on the outcomes of therapies that are used by large numbers of elderly persons, youth and other patients," Crystal said.
"We are very pleased that the important program of work at the institute on the use and outcomes of mental health medications has been recognized by this award," added Professor David Mechanic, director of the IHHCPAR.
The Rutgers Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes was created in 2005 with seed money from Rutgers' Academic Excellence Fund.