AstraZeneca says benefits of Seroquel in depression confirmed in second study

New York, May 23 - AstraZeneca said results of a second study of Seroquel (quetiapine fumarate) as a monotherapy treatment for depressive episodes in patients with bipolar I and II disorders confirmed the findings of earlier research.

The Bolder (BipOLar DEpRession) II study showed significant improvement in measures of depressive symptoms in patients taking Seroquel, confirming the results of the Bolder I study, according to results presented in posters at the American Psychiatric Association meeting in Toronto.

The double-blind Bolder II research involved 509 depressed patients with bipolar I or II disorder who received eight weeks of either Seroquel (300 or 600 mg/day) or a placebo.

Patients were assessed weekly using Madrs (Montgomery-Asberg Depression Rating Scale) and HAM-D (Hamilton Rating Scale for Depression) rating scales. The primary endpoint was the reduction in Madrs total score from baseline at week eight.

Results showed that the mean reduction from baseline in the Madrs total score was significantly greater with Seroquel than with the placebo as early as week one, with continued improvement through week eight.

Reduction in mean HAM-D total score was significantly greater with both Seroquel doses than with the placebo as early as week one, with improvement continuing through the study's endpoint.

There were significant improvements demonstrated in other secondary outcome measures as well.

Common adverse events included dry mouth, sedation, somnolence and dizziness. Generally, adverse events were mild to moderate in intensity, AstraZeneca said. Discontinuation rates due to adverse events were 8.2% (300 mg/day), 11.3% (600 mg/day) and 1.2% (placebo).

Seroquel is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.

On Dec. 30, 2005, AstraZeneca submitted a supplemental New Drug Application to the Food and Drug Administration to seek approval for Seroquel in the treatment of patients with depressive episodes associated with bipolar disorder.

AstraZeneca is a London-based pharmaceutical company.

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