AstraZeneca cheered by more promising depression data

Confirming the results of an earlier study, AstraZeneca's Seroquel (quetiapine fumarate) has demonstrated significant improvement in measures of depressive symptoms in a large-scale study examining the drug as a monotherapy in patients with bipolar I and II disorders.

In the study, named BOLDER II, depressed patients with bipolar I or II disorder were randomized to eight weeks of double-blind treatment with Seroquel (quetiapine fumarate) 300 or 600mg/day or placebo. The primary endpoint was the reduction in Montgomery-Asberg depression rating scale (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 placebo as early as week one, with continued improvement through week eight.

Approximately 50% of patients taking Seroquel achieved remission from bipolar depression symptoms at endpoint.

BOLDER II, and earlier study BOLDER I, also examined the effect of Seroquel on suicide-related symptoms in depressive episodes of bipolar disorder. In a post-hoc analysis of 1,045 patients, mean MADRS item 10 score (suicidal thoughts) decreased significantly more with both Seroquel doses than placebo at week eight.

“Results from BOLDER II are remarkably similar to those found in BOLDER I, the first large-scale study that examined Seroquel treatment of depressive episodes in bipolar I and II patients,” said Dr Michael Thase, lead investigator of BOLDER II and a professor of psychiatry at University of Pittsburgh Medical Center. “In the past, doctors have typically treated bipolar disorder with both a mood stabilizer and an antidepressant. Having a single medication to treat both the manic and depressive episodes of this condition would be a significant medical advance.”