New York — Patients with bipolar disorder may be eligible for a new clinical research study comparing two medications—quetiapine (Seroquel), a widely prescribed second-generation antipsychotic mood-stabilizing medication, and lithium, the gold-standard mood stabilizer.
New York-Presbyterian Hospital/Weill Cornell Medical Center is one of 10 sites nationally—and the only site in the greater New York metropolitan area—participating in the CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness) study. The research is funded by a $10 million grant from the U.S. Agency for Healthcare Research Quality (AHRQ).
"Antipsychotic drugs have long been known to be useful for the treatment of bipolar disorder, but neurological side effects and toxicity have limited their long-term use. The good news is that the newer-generation antipsychotic drugs like quetiapine appear to be effective while having fewer neurological side effects," says Dr. James H. Kocsis, site principal investigator, director of the Payne Whitney Affective Disorders Research Clinic at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and professor of psychiatry at Weill Cornell Medical College.
"In this context, it is important that we compare the relative utility of the old-fashioned mood stabilizers like lithium and the newer second-generation antipsychotic drugs—with the ultimate goal of improving long-term treatment for patients with bipolar disorder."
Researchers will follow 480 patients with bipolar disorder randomized to one of the two medications over a six-month period. Participants can continue taking other prescriptions, such as antidepressants, as long as they are not antipsychotic drugs. Often patients with bipolar disorder need three medications to feel well, explains Dr. Kocsis.
Bipolar disorder is a lifelong, chronic and highly recurrent mood disorder characterized by episodes of mania that alternate with episodes of major depression. Symptoms can negatively affect personal relationships, job or school performance, and may result in suicide.
The study is coordinated through the Massachusetts General Hospital (MGH) Bipolar Clinic and Research Program. The lead principal investigator is Dr. Andrew A. Nierenberg, director of the MGH Bipolar Research Program.
The AHRQ grant is part of an investment 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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