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June 28, 2005

Seroquel Effective at Treating Bipolar Disorder

New information on Seroquel was presented at the annual American Psychiatric Association meeting in San Francisco that show it is effective at treating mania in those with bipolar disorder. Seroquel is more commonly used to treat schizophrenia.

The following information looks like it comes (either directly, or indirectly) from AstraZeneca's marketing department - so, as with any marketing material from any company, we think you should be skeptical of the information. It looks interesting, but all company marketing departments tend to highlight the positive points of their products, while avoiding mention of any possible negative aspects, and pharmaceutical companies are no different in this respect. The most reliable information is generally from independent sources (with no monetary ties to the medication), such as NIMH (National Institute of Mental Health) – sponsored studies.

AstraZeneca today announced new data, presented at the 156th annual meeting of the American Psychiatric Association (APA) in San Francisco, which indicate that SEROQUEL (quetiapine) is effective, well tolerated and fast-acting when used as monotherapy for the treatment of mania associated with bipolar disorder.

"Today's results add to previous clinical studies that show SEROQUEL can provide relief of disease symptoms without the troublesome side effects sometimes associated with other treatments, making it an acceptable treatment for bipolar disorder, where patient compliance is paramount,” commented Bill Bastain, Vice President and Head, Neuroscience Therapy Area, AstraZeneca.

A pooled analysis of the data from two 12-week trials, which tested SEROQUEL monotherapy vs. placebo, showed that after three weeks, SEROQUEL achieved significantly greater improvements in the Young Mania Rating Scale (YMRS) total score from baseline compared to the placebo group (-13.58 and –7.76, respectively, p<0.0001). In patients treated with SEROQUEL, a statistically significant improvement in YMRS total score was observed as early as day four (p=0.021) and at each subsequent time point until day 84 (p<0.001). SEROQUEL was also well tolerated by patients in the trials.

These results support a previous study, which showed that SEROQUEL, in combination with a mood stabiliser (lithium or divalproex), was significantly more effective than a mood stabiliser alone in treating bipolar mania. AstraZeneca announced its submission of a Supplemental New Drug Application to the U.S. Food and Drug Administration in January 2003 and to the 14 European Member States involved in the Mutual Recognition Procedure in February 2003, for SEROQUEL to be granted a license for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness).

Bipolar Disorder affects approximately 3-4 per cent of the adult population and is ranked as the second leading cause of disability worldwide among the neuro-psychiatric disorders.

One of the issues faced by psychiatrists treating this condition are the problems associated with treatment compliance due to tolerability issues with some treatments. More than half of those with bipolar disorder stop taking their medication at some point during their lives, subjecting themselves to a high risk of relapse and an increased risk of suicide.

To go to the press release on the AstraZeneca website go to: http://www.astrazeneca.com/pressrelease/494.aspx

For the Seroquel website go to: http://www.seroquel.com/

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