Seroquel XR approved for bipolar depression and mania
Date Posted: October 10, 2008
AstraZeneca’s Seroquel XR (quetiapine fumarate extended-release tablets)
has been approved for the treatment of depressive episodes in bipolar disorder, manic and mixed episodes in bipolar I disorder, and the maintenance treatment of
bipolar I disorder as adjunct therapy to lithium or divalproex.
In a clinical trial of 280 patients, Seroquel XR was significantly more effective than placebo in treating bipolar depression as measured by the
Montgomery-Asberg Depression Rating Scale (MADRS). In a second trial of 316 subjects, Seroquel XR significantly improved the symptoms of bipolar mania or mixed episodes
as measured by the Young Mania Rating Scale (YMRS) compared to placebo.
Seroquel XR is already indicated
for the treatment of schizophrenia.