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University of Iowa News Release

May 27, 2003

UI Invites People For Schizophrenia Study

Aripiprazole, the newest antipsychotic medication on the market, has been added to a clinical trial at the University of Iowa. Aripiprazole is the latest schizophrenia drug to receive approval for market use from the U.S. Food and Drug Administration (FDA).

People ages 18 to 65 with schizophrenia are invited to participate in the ongoing UI study on the long-term effects and usefulness of antipsychotic drugs for persons with the condition. Enrollment in the study ends June 30, 2003.

The study compares a conventional antipsychotic medication and six newer antipsychotic medications for the treatment of schizophrenia. Participants will make 20 visits to the UI Roy J. and Lucille A. Carver College of Medicine over the course of 18 months and will be asked to designate a family member to participate in an optional series of telephone interviews during the study period. Limited compensation for travel expenses is available.

Participants randomly will be assigned to take either the conventional treatment, perhenazine (Trilafon), or one of five newer drugs: olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), ziprasidone (Geodon) or clozapine (Clozaril) and to stop their current antipyschotic medication. Depending on how each individual responds to the medication, he or she may remain on the same medication or switch to another medication during the course of the study. Some participants may qualify for the newest FDA approved antipsychotic drug aripiprazole (Abilify).

The UI is one of 50 sites nationwide that are participating in this study, one of two trials in the Clinical Antipsychotic Trials of Interventions Effectiveness (CATIE). The study is sponsored by the National Institute of Mental Health. The UI portion of the study is led by Del Miller, Pharm.D., M.D., UI associate professor of psychiatry. He explained that aripiprazole was added to ensure that the study results are relevant to current clinical practice.

Unlike first-generation antipsychotic agents, which act primarily on the brain's dopamine system, the newer drugs being studied by the CATIE project also act on serotonin and other neurotransmitter systems. The newer drugs also cost several times more than the first-generation antipsychotics. Project results will help determine if the newer drugs are effective and whether they are worth the higher price.

For more information, contact Tim Holman, research assistant in psychiatry, at 319-335-6769, or Jane Kerr, research assistant in psychiatry, at 319-353-4955. Toll-free inquiries may be made through UI Health Access at 800-777-8442. Information also is available online at www.catie.unc.edu.

STORY SOURCE: University of Iowa Health Science Relations, 5137 Westlawn, Iowa City, Iowa 52242-1178

MEDIA CONTACTS: Media: Becky Soglin, 319-335-6660, becky-soglin@uiowa.edu
Prospective Study Participants: Tim Holman, 319-335-6769, timothy-holman@uiowa.edu

NOTE TO EDITORS: This release originally was distributed April 9, 2003. Participants still are sought, and this release explains why the newest study drug, aripiprazole, was added.