In an effort to foster comprehensive research, the University received a $2.3 million grant from the Agency for Healthcare Research and Quality and the Food and Drug Administration to lead a major study on antipsychotic medications.
The study’s focus will be on the use, safety and effectiveness of the medications with the development of antipsychotic drugs that have been perceived as safer than older drugs, said Research Professor Stephen Crystal of Rutgers’ Institute for Health, Health Care Policy and Aging Research.
“We have been trying to develop a program at Rutgers in the area of Pharmaco Epidemiology, and we have tremendous resources in related areas like pharmacy and health care policy,” Crystal said. “It’s a very interesting and promising area to develop within the University and having this study enables us to do that, and it also helps us to develop very unique databases that can be used to support a lot of different kinds of research.”
Although these newer medications have been perceived as safer, evidence remains incomplete on the actual safety and effectiveness of the drugs, according to AHRQ’s and FDA’s requests for applications.
“You can have a lot of debates as to whether a particular drug was studied enough, and you can also have debates about how much control the government should have about health care,” Crystal said. “Where that leaves [the researchers] and the funders of these particular studies is that you need different kinds of studies to answer different questions.”
Antipsychotic medications have become widely used among a clinically-diverse population, including children and adolescents with behavioral disorders, the elderly with symptoms of dementia, and adults with schizophrenia and other serious mental illnesses, Crystal said.
“They can use [the findings from the research] to apply to the student body because suicide rates for undergraduate students have been increasing,” said Atif Ashraf, a School of Arts and Sciences sophomore. “Also, students have become dependent on a lot of things at our school. Sometimes it’s caffeine pills or anti-sleeping pills, so the antipsychotic medications could help them with that.”
As the medications have a widespread use, particular concerns have risen among the youth and the elderly, whom the AHRQ and FDA defined as the primary focus of the research project, Crystal said.
“Off-label use is very relevant. These drugs are sometimes prescribed to people who have [attention deficit hyperactive disorder]. There’s an increase in prescriptions for depression and diagnoses of bipolar disorder, which are very common in the college age student population,” Crystal said. “We all have families, grandmas in the nursing homes and younger siblings who may have a behavioral problem, so this research is very relevant.”
The University partnered with the Harvard Medical School/Brigham and Women’s Hospital, Vanderbilt University and Columbia University when compiling the study. The researchers will divide into investigative teams conducting three sub-studies, according to a press release.
“We are the lead center, which means we are responsible for overall management of the project, and coordinating and overseeing the work of all centers,” Crystal said. “But it takes a lot of different expertise to do something like this. For example, you need excellent expertise in psychology, pharmatology, database systems and statistics. You can’t find all of those at any one institution.”
The first sub-study will focus on medical outcomes such as mortality, stroke, myocardial infarction, cognitive function and behavioral symptoms of dementia in institutionalized elderly patients, according to the press release.
Using a dataset developed through the AHRQ-funded Center for Education and Research on Mental Health Therapeutics, the University team will expand the research along with Harvard investigators on medication outcomes on several million nursing home residents throughout the nation, according to the release.
The second sub-study to be led by Vanderbilt investigators will examine medication outcomes for children and adolescents. The investigators will combine analyses of Medicaid claims, medical charts and electronic medical record data in Tennessee with University-based analyses of national Medicaid data, according to the release.
The third sub-study will examine several population-wide safety issues throughout many ages, including risks of pituitary tumors, diabetes and outcomes for elderly with dementia who live in the community, according to the release.
“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,” said Professor David Mechanic, the director for the institute.
The AHRQ application process begins with a request by the federal agency that then receives applications from various institutions. Those applications are assigned to a peer review group or to a special emphasis panel, said Joan Metcalf, the grants management officer for the AHRQ.
“The AHRQ and FDA issued a Request for Proposals, and we developed a research plan and funding application in response, as did other applicants,” Crystal said. “Our application received the best priority score.”
The federal agency then decides which applications to fund based on scientific and technical merit, agency research priorities and availability of grant funds, according to the release.
“All of our grants are research grants based on competitive scientific merit,” Metcalf said. “The primary reason why Rutgers was chosen for this research project is scientific merit.”
Institute awarded $2.3M grant
Money allotted to research, development of new antipsychotic medications
Published: Tuesday, November 4, 2008
Updated: Tuesday, November 4, 2008
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