For Immediate Release
UNC-Chapel Hill receives additional $18 million, expands "real world" clinical trials of schizophrenia and Alzheimer's drugs
by Sheryl W. McKelveyDepartment of Psychiatry/UNC-Chapel Hill School of Medicine
CHAPEL HILL - The University of North Carolina's Department of Psychiatry is expanding its large-scale effectiveness trials of anti-psychotic medications for schizophrenia and behavioral problems in Alzheimer's disease to include a newly-approved drug. The National Institute of Mental Health (NIMH) is providing an additional $18 million to the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project, bringing the total contract to $60 million.
The two CATIE trials are examining which of the new generation of anti-psychotic drugs are best for patients with schizophrenia and disruptive behaviors associated with Alzheimer's disease. Completion of the trials is set for September 2004, but terms of the NIMH contract include an option for a five-year extension and expansion studies.
The study was originally designed to examine the effectiveness of the various classes of anti-psychotic drugs represented by clozapine, risperidone, olanzapine, quetiapine and perphenazine. Now ziprasidone, which received Food and Drug Administration (FDA) approval last February, will be added to the schizophrenia trial.
Once the FDA deemed ziprasidone effective in treating psychosis in schizophrenia, CATIE investigators proposed adding it to enhance the scientific value and clinical relevance of the study's results.
"The major objective of the CATIE trials is to determine the most effective treatments in real-world settings, so it's important that we examine new medications as they become available to patients," explained Dr. Jeffrey A. Lieberman, CATIE's principal investigator. Lieberman is a professor of psychiatry, pharmacology and radiology at the UNC-Chapel Hill School of Medicine.
"Unlike smaller studies of the past, the CATIE trials embrace a broader public health model of intervention," said NIMH Acting Director Richard K. Nakamura, Ph.D. "We hope to gain important information on cost effectiveness and patient adherence to the treatment."
Unlike first generation anti-psychotic agents, which act primarily on the brain's dopamine system, the newer drugs being studied by the CATIE project also act on serotonin and nonrepinephrine systems. They also cost at least 10 times more than the first generation anti-psychotics. CATIE results will help determine if they are effective and whether they are worth the higher price.
"The relative effectiveness of ziprasidone and other drugs in the study is undetermined," Dr. Lieberman said. "CATIE research will provide a definitive comparison so that health-care providers can make informed choices about treatment."
CATIE is a multi-institutional effort led by UNC-Chapel Hill and managed by Quintiles Inc. of Research Triangle Park, N.C. UNC-Chapel Hill is working with other academic centers to coordinate the trials, involving faculty from Duke University, the University of Southern California, Yale University and the University of Rochester.
Dr. Lieberman and Dr. C.E. Davis, professor and chair of biostatistics at the UNC-Chapel Hill School of Public Health, are the project's co-principal investigators. Lon Schneider, M.D., professor of psychiatry, neurology, and gerontology at USC, and Pierre Tariot, M.D., professor of psychiatry and neurology at the University of Rochester direct the Alzheimer's disease trials.
Key investigators from UNC-Chapel Hill are Scott Stroup, M.D., M.P.H., and Diana Perkins, M.D., M.P.H. Other researchers involved in trial management are Joseph McEvoy, M.D., Marvin Swartz, M.D., and Richard Keefe, Ph.D. at Duke and Robert Rosenheck, M.D. at Yale.
UNC-Chapel Hill was tapped for the project in 1999 and began enrolling participants in December 2000. Currently, 90 clinical sites in 38 states have enrolled more than 700 patients. Sites in North Carolina include UNC-Chapel Hill; Duke; John Umstead Hospital in Butner; Dorothea Dix Hospital in Raleigh; Wake Forest University School of Medicine in Winston-Salem; and the Behavioral Health Center in Charlotte.
Media Note: Contact Dr. Jeffrey Lieberman at (919) 966-8990, [email protected]
Contact Sheryl McKelvey at (919) 843-3784, [email protected]
Please see attached for trial locations
CATIE TRIAL LOCATIONSSchizophrenia and Alzheimer's disease studies are being conducted at the following locations:
Alabama Tuscaloosa VA Medical Center
California University of Southern California/Dept of Psychiatry & Behavioral Sciences, Los AngelesSynergy Clinical Research, Chula VistaUniversity of California, Los Angeles, VA Medical CenterStanford University School of MedicineHarbor UCLA Research & Education Institute, TorranceUniversity of California, IrvineUniversity of California-San Diego, VA Medical CenterVA-San Diego Healthcare System, La JollaLA County-University of Southern California Medical Center, Los Angeles
ConnecticutYale University/Connecticut Mental Health Center, New HavenNew Britain General Hospital, New Britain
Florida Henderson Mental Health Center, Ft. Lauderdale University of Miami School of MedicineVA Medical Center, MiamiUniversity of South Florida Suncoast Gerontology Center, TampaPalm Beach Neurology/Premier Research Institute, West Palm BeachMental Health Associates, Inc., Boca Raton
Georgia Emory University School of Medicine, AtlantaWesley Woods Health Center, Atlanta
Hawaii The Queen's Medical Center, HonoluluUniversity of Hawaii, Honolulu
Illinois Northwestern Medical School Department of Psychiatry/Northwestern Medical School, ChicagoNorthwestern University Medical SchoolSIU School of Medicine, SpringfieldSouthern Illinois School of Medicine, Springfield
IowaUniversity of Iowa College of Medicine, Iowa CityKansas Psychiatric Research Institute, Outpatient Clinic, Wichita
Louisiana Louisiana State University Health Services Center, Shreveport
Maryland Clinical Insights, Inc., Glen BurnieJohns Hopkins University, Baltimore
Massachusetts Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program, BostonSt. Elizabeth's Medical Center, BostonUniversity Of Massachusetts Health Care, Worcester Corrigan Mental Health Center, Fall River
Mississippi University of Mississippi, Jackson
Missouri Burrell Behavioral Health-Cox North Hospital, SpringfieldUniversity of Missouri Kansas City Medical SchoolWashington University School of Medicine, St. LouisSt. Louis University School of Medicine-Wohl Institute
New Hampshire Dartmouth Hitchcock Medical Center, LebanonDartmouth Hitchcock Medical Center, ManchesterFrisbie Memorial Hospital, Rochester
New Mexico Albuquerque VA Medical Center
New York Columbia University, New YorkStaten Island University HospitalMount Sinai Medical Center-Bronx VA Medical CenterMount Sinai Medical Center, New YorkMonroe Community Hospital, Rochester Nathan S. Kline Institute, Orangeburg University of Rochester Medical Center
North Carolina University of North Carolina School of Medicine, Chapel Hill Dorothea Dix Hospital, Raleigh Duke University Medical Center, DurhamDuke University Medical Center-John Umstead Hospital, ButnerWake Forest University School of Medicine, Winston Salem Behavioral Health Center, Charlotte
Ohio Appalachian Psychiatric Healthcare System, AthensUniversity Hospitals Health Systems, Willoughby
Pennsylvania Eastern Pennsylvania Psychiatric Institute, PhiladelphiaBehavioral Health Service, Philadelphia University of Pittsburgh AD Research Center Mental Illness Research Education and Clinical Center, Philadelphia VA Medical Center, Coatesville
South Carolina Medical University of South Carolina, Charleston Veterans Affairs Medical Center, Charleston
Tennessee Vanderbilt University Medical Center, Nashville
Texas Tri-County MHMR Services, Conroe University of Texas Southwestern Medical Center, Dallas MHMRA of Harris County-Northwest Community Service Center, Houston Life Management Center for MH/MR Services, El PasoThe Center for Health Care Services, San AntonioUniversity of Texas Health Sciences, San Antonio
Utah Valley Mental Health Psychopharmacology Research Center, Salt Lake City
Washington VA Puget Sound Health Care System, Tacoma
###
RSS