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(HealthNewsDigest.com) – Researchers at the Stanford University School of Medicine are launching a study to compare two commonly prescribed medications for the treatment of bipolar disease. Their work is part of a multi-center, federally funded study.
“We hope to determine the better foundational treatment for the contemporary management of bipolar disorder,” said Terence Ketter, MD, principal investigator of the Stanford arm of the study and director of Stanford’s Bipolar Disorders Clinic. “Is it lithium, the classical mood stabilizer, or quetiapine, a second-generation antipsychotic with broad efficacy in bipolar disorder?”
Ketter and his colleagues are now looking for participants for their clinical study. To qualify, subjects must be ages 18 to 65 and have a diagnosis of bipolar disorder. People who have taken lithium or quetiapine (brand name Seroquel) within the last 30 days are excluded from participating. Those interested can receive more information by calling Shelley Hill at (650) 498-4801 or emailing [email protected].
Bipolar disorder, which affects more than 10 million U.S. adults, is a chronic mood disorder that causes dramatic shifts in a person’s mood, energy and ability to function. The disorder ranks among the top 10 causes of disability worldwide and, according to a 2008 American Journal of Psychiatry study, treatment and prevention costs in the United States total more than $70 billion each year.
Two commonly prescribed medications for bipolar disorder are lithium and the antipsychotic quetiapine. Neither drug is perfect: Lithium is associated with the risk of long-term thyroid and kidney problems, and quetiapine carries the risk of drowsiness and weight gain and increases the risk of cardiovascular disease and metabolic problems such as diabetes. But, Ketter noted that these risks can be managed by careful attention to dosage and, on occasion, use of other medications.
While patients have historically been given lithium — which is available in generic form — treatment of bipolar disorder has shifted away from lithium over the past 10 years and toward newly developed antipsychotics such as quetiapine. Ketter said that he suspects one of the reasons for the shift is the marketing efforts of the companies that manufacture these newer drugs.
“I think having new treatment options is a good thing, but I also think putting aside older treatment options ought to be based on evidence rather than novelty or promotional considerations,” said Ketter, professor of psychiatry and behavioral sciences.
Ketter along with co-investigator Po Wang, MD, clinical associate professor of psychiatry and behavioral sciences, and their colleagues are seeking evidence on the efficacy and tolerability of lithium compared with quetiapine. Forty-eight patients at Stanford will be randomized to receive one of the two drugs, plus other necessary treatments. The participants will be monitored for 24 weeks.
Ketter pointed out that industry-sponsored efficacy studies, aimed at assessing treatments for bipolar disorders in order to gain FDA approval, usually allow participants to take one other medication at the most. But, Ketter said, this comparative-effectiveness study is different because participants can be treated with almost any other medication — except lithium for patients randomized to quetiapine, or quetiapine for patients randomized to lithium. (Most bipolar disorder patients need combinations of medications to manage their disease.)
Ketter said the results of the trial should shed light on which patients respond better to lithium, and which respond better to quetiapine, and could help guide future treatment decisions.
The study, which will include 480 patients nationwide, is funded by a $10 million grant from the Agency for Healthcare Research Quality. The 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.
More information about the Stanford Bipolar Disorders Clinic is available at http://www.bipolar.org
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