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Release: March 26, 2001

UI is part of national mental health clinical trial

IOWA CITY, Iowa -- University of Iowa Health Care researchers will take part in a five-year, National Institute of Mental Health-sponsored study that is being called the largest clinical trial ever attempted in the mental health field.

The $43 million study, led by University of North Carolina researchers, includes scientists from 50 medical centers across the country. It will compare the effectiveness of four new antipsychotic medications against an established, conventional antipsychotic medication. The study will determine whether the newer medications actually work better, are better tolerated and lead to improved patient satisfaction.

The study will require the participation of approximately 1,800 individuals with schizophrenia nationwide. The UI will seek to enroll 30 participants over the next two years, and each person will be followed for up to two years.

"There has been little research comparing these different newer generation drugs to each other, and the studies that have been done have mostly been sponsored by the pharmaceutical industry," said Del Miller, Pharm.D., M.D., UI associate professor of psychiatry and principal investigator for the Iowa portion of the study. "This will be an unbiased, independent study comparing the efficacy and safety of these drugs in one large study."

Antipsychotic medications have been prescribed since the 1950s to control the positive symptoms -- hallucinations (voices) and delusions (misperceptions) -- in patients with schizophrenia. In the past 10 years, four new "atypical" antipsychotic medications have hit the market, providing the same or greater benefits without many of the side effects that could affect people taking the older medications. Those side effects include body stiffness, spasms and movement disorders.

"Even though these newer medications seem to have advantages over the older medications, there is still a question whether the risk-benefit ratio of the new medications is better than the older medications over the long term," Miller said. He noted that the newer medications have their own side effects. Significant weight gain has been shown with some of the newer agents, which could increase a patient's risk for diabetes, high blood pressure and cardiovascular disease.

Patients and medical insurers will be interested in the study's overall findings for another reason: cost. The newer antipsychotic drugs can cost hundreds of dollars per month; the older medications are as little as $10-$20 per month. Preliminary studies suggest that although the cost of the newer medications is higher, they can lead to an overall cost saving by reducing other medical costs, such as inpatient hospitalization, associated with schizophrenia. This large trial will be able to directly address this issue.

Patients with schizophrenia in the double-blind, randomized trial will receive one of the four newer medications or the conventional antipsychotic medication. The researchers will begin enrolling participants in the coming weeks.

Miller noted that the study will be a "real-world" trial, meaning that the criteria for enrollment will be less stringent than industry-sponsored drug studies, and that patients who are not responding or are not happy with their assigned medication can be re-randomized to another medication being tested. In most industry-sponsored studies, these patients would be dropped from the study altogether.

Miller will lead the research effort in persons with schizophrenia at the UI. A related study involving persons with Alzheimer's disease will start later this month and will be directed by Susan Schultz, M.D., UI associate professor of psychiatry. This study will examine the effectiveness of the newer medications for psychosis and agitation in community-dwelling patients with Alzheimer's disease.

"This will be an important study in terms of what we learn, but also in that it could lead to additional large-scale studies involving any number of medications used to treat psychiatric disorders," Miller said.

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