ANN ARBOR, Mich. - The University of Michigan is participating in a new clinical trial to compare the effectiveness of two medicines commonly used to treat bipolar disorder.
U-M is one of 10 sites in the Bipolar Trials Network that will participate in the national study, which is supported by a federal investment aimed at improving patient outcomes.
The Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness) trial will compare the real-world performance of quetiapine, a widely prescribed mood-stabilizing medication, with lithium, a standard for outpatient bipolar treatment for many years.
"This research is a true collaboration, involving not only other leading U.S. institutions, but also a group of dedicated individuals with bipolar disorder who are enthusiastic about contributing their time to participate in our research," says Melvin McInnis, M.D.,the principal investigator for Bipolar CHOICE at U-M. "Our study participants are our most valuable collaborators, since they are highly motivated to help us understand and manage this illness more effectively."
Unlike most other trials, the study permits participants to take almost any other medication. Although many patients need about three medications to feel and stay well, most studies comparing treatments for bipolar disorder do not permit patients to take other medications besides those being evaluated.
With the support of the Heinz C. Prechter Bipolar Research Fund, the U-M Depression Center and Department of Psychiatry have also established a genetic and biological repository on bipolar disorder. The repository is part of the first "translational" project to integrate genetic, longitudinal biomedical and clinical outcome measures.
"It is very exciting to be able to offer our research participants the opportunity to take part in Bipolar CHOICE and our other research projects, particularly research into treatments conducted in collaboration with other top institutions in the county," says McInnis, who is also the Thomas B. and Nancy Upjohn Woodworth Professor of Bipolar Disorder and Depression in Psychiatry, and an associate director of the Depression Center.
The Bipolar CHOICE study is funded by a grant from the Agency for Healthcare Research Quality. The AHRQ grant is part of an investment made under the American Recovery and Reinvestment Act of 2009 that 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. Of the 10 grants (totaling $100 million) awarded under this umbrella, Bipolar CHOICE is the only one to study mental illness.
Both drugs involved in the study 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.
Additional information on clinical trials can be found at umclinicalstudies.org.
About bipolar disorder:
Bipolar disorder is a lifelong, highly recurrent disorder characterized by extreme variations in mood, alternating between episodes of mania or hypomania (states of elevated mood) and major depression. Bipolar disorder ranks among the top 10 causes of disability worldwide, with associated costs of $70.6 billion per year for treatment and prevention.
Proper management of bipolar disorder, often through a combination of medication and psychotherapy, can help most people gain control over their mood swings and related symptoms.
U-M Department of Psychiatry, www.psych.med.umich.edu
U-M Depression Center, www.depressioncenter.org