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Case Western Reserve/UH Launch Bipolar CHOICE Trial Site

STUDY JOINS 10 SITES NATIONALLY TO EXAMINE ‘REAL WORLD’ USE OF MEDICATIONS, QUETIAPINE AND LITHIUM

January 11, 2011

CLEVELAND - The Mood Disorders Program at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, along with the Bipolar Trials Network, is launching Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness). The 10-site nationwide trial evaluating the real-world advantages and disadvantages of quetiapine, a widely prescribed second-generation antipsychotic mood-stabilizing medication, compared to lithium, the gold standard mood stabilizer, for the treatment of outpatients with bipolar disorder. The study is funded by a $600,000 grant to Case Western Reserve University School of Medicine from the Agency for Healthcare Research Quality. The trial will begin enrolling patients January 11, 2011. Bipolar disorder is a lifelong, chronic and highly recurrent, mood disorder characterized by episodes of mania or hypomania that alternate with episodes of major depression. Its course is often chronic and yields a high degree of human suffering which places the disorder among the top 10 causes of disability worldwide with associated costs of $70.6 billion per year for treatment and prevention. “Studies that compare treatments for bipolar disorder usually don’t allow participants to take other medications and most patients need several medications to feel and stay well, says Joseph R. Calabrese, M.D., Professor of Psychiatry at Case Western Reserve School of Medicine and Director of the Mood Disorders Program at University Hospitals Case Medical Center and Principal Investigator of Bipolar CHOICE, “Bipolar CHOICE is unique because participants can be treated, not only with quetiapine or lithium, but with almost any other medication excluding other antipsychotics.” Over the past 10 years, the pharmacologic treatments for bipolar disorder have shifted away from lithium – which is available as a generic medication – in favor of newly developed antipsychotics, such as quetiapine. Both drugs have well documented side effects. Quetiapine has the risk of drowsiness, weight gain, and increases the risk of cardiovascular disease. Lithium is associated with the risk of long-term thyroid and kidney problems. Dr. Calabrese believes that this study distinguishes itself as having the potential of making a real pragmatic contribution to the treatment of patients with bipolar disorder. He states that “Future trials need to focus on effectiveness, not just on whether one treatment appears better than placebo. We need studies that inform the day-to-day practice of psychiatry in a meaningful way. With real world studies in psychiatry viewed as being unusual, this study has the potential of doing just that.” The AHRQ grant is part of an investments made under the American Recovery and Reinvestment Act of 2009 which designated $1.1. billion to support patient-centered outcomes research. This research is designed to inform health care decisions by providing evidence and information on the effectiveness, benefits and harms of different treatment options. Ten grants totaling $100 million were awarded across the country and this particular one was the only one awarded to study mental illness. Prospective study participants can receive more information by calling 216-844-2869 or at Sarah.Obral@UHhospitals.org. More information about the Mood Disorders Program may be found at www.case.edu/mdp. Among the nation’s leading academic medical centers, University Hospitals Case Medical Center is the primary affiliate of Case Western Reserve University School of Medicine, a nationally recognized leader in medical research and education.

Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine.

Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report's "Guide to Graduate Education."

The School of Medicine is affiliated with University Hospitals Cleveland Medical Center, MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002. case.edu/medicine.