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AstraZeneca: Study shows Seroquel effective for bipolar depression
By E. Janene Geiss
Philadelphia, Oct. 21 - AstraZeneca announced Friday that top-line results of a study of its drug Seroquel show potential in the treatment of major depressive disorders.
In a company news release, officials said a Bolder II study of Seroquel at 300 mg and 600 mg doses achieved a statistically significant reduction in the levels of bipolar depression compared with placebo.
Results of the eight-week, placebo-controlled study reinforces the findings of the Bolder I study published in the American Journal of Psychiatry in July, which first indicated a significant effect for Seroquel in treating major depressive episodes associated with bipolar disorder, officials said.
Officials said the drug was shown to be well tolerated in the Bolder II study with a similar safety profile seen to that in Bolder I. The rate of serious adverse events was low and comparable in all treated groups.
"Patients with bipolar depression are underserved and understudied. The findings ... are very encouraging," Joseph Calabrese, co-director of the National Institute of Mental Health Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University, said in the release.
Both studies represent the largest placebo-controlled short-term studies ever conducted in bipolar depression, Calabrese noted.
Bipolar disorder is a serious mental illness that affects about 3% to 4% of adults and is the sixth leading cause of disability in the world.
AstraZeneca, with headquarters in London, is a pharmaceutical company focused on development, manufacture and marketing of prescription pharmaceuticals.
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