Alderley Park, Cheshire, UK, 21 October 2005: - Newly released top-line results from the BOLDER II (BipOLar DEpRession) study have underlined the potential for SEROQUEL (quetiapine fumarate) in the treatment of patients with major depressive episodes associated with bipolar disorder. In BOLDER II, SEROQUEL 300mg and 600mg doses achieved a statistically significant reduction in levels of bipolar depression compared with placebo (p<0.001), as measured by the change from baseline in MADRS* total score.1

BOLDER II, an eight week, multi-centre, placebo-controlled study, reinforces the findings of the landmark BOLDER I study2 published in American Journal of Psychiatry in July 2005, which first indicated a significant effect for SEROQUEL in treating major depressive episodes associated with bipolar disorder.

In BOLDER II, the significant reduction in MADRS total score was seen both in patients with bipolar I and bipolar II disorder, in patients with or without a rapid cycling course of illness, and as early as week one after randomisation. Significant improvements were also seen compared with placebo in the various secondary study endpoints among SEROQUEL-treated patients, including reduction of anxiety symptoms. In addition, more than half (53%) of patients receiving SEROQUEL achieved remission** from their bipolar depression symptoms.

Importantly, SEROQUEL was shown to be well tolerated in BOLDER II 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. The most common adverse events reported in the trial were dry mouth, sedation, somnolence, dizziness and constipation, and there was a low incidence of treatment-emergent mania in the SEROQUEL-treated groups.

As in BOLDER I, there was a low incidence of EPS (extrapyramidal symptoms) and minimal weight change reported in the study.

* MADRS (Montgomery- sberg Depression Rating Scale) measures the seve
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Contact: Maren Koban
maren.koban@hillandknowlton.com
Hill and Knowlton
21-Oct-2005

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