The Massachusetts General Hospital (MGH) Bipolar Clinic and Research Program with the Bipolar Trials Network is launching Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness), a 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 $10 million grant from the Agency for Healthcare Research Quality (AHRQ).
Bipolar disorder is a lifelong and highly recurrent mood disorder characterized by episodes of mania or hypomania that alternate with episodes of major depression. It is 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, but most patients need about three medications to feel well and stay well. Bipolar CHOICE is unique because participants can be treated not only with quetiapine or lithium, but with almost any other medication -- except other antipsychotics - in order to help them feel better," says Andrew A. Nierenberg, MD, director of the MGH Bipolar Research Program and the principal investigator of Bipolar CHOICE.
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.
"A real-world effectiveness study may uncover considerable differences regarding the risks of adverse effects, costs, and adherence to treatment. If such differences are found, the results of this study would have immediate and profound implications for clinical treatment decisions," says Louisa Sylvia, PhD, director of Clinical Operations of Bipolar CHOICE.
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.
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