Combined Data From Four Large-Scale Studies Demonstrate The Efficacy And Tolerability Of Seroquel In Bipolar Depression

Results presented today at the 162nd American Psychiatric Association (APA) congress in San Francisco, CA, demonstrated the efficacy and tolerability of SEROQUEL® (quetiapine fumarate) for treating depressive episodes in bipolar disorder, including the difficult-to-treat bipolar II patient population.1,2 The data are from combined analyses of four large-scale clinical trials to examine SEROQUEL as a treatment for depressive episodes associated with bipolar I and II disorders. SEROQUEL and SEROQUEL XR™, a once-daily, extended-release formulation of SEROQUEL, is one of the most widely studied atypical antipsychotic in bipolar depression and the only agent approved as monotherapy to treat the spectrum of mood episodes associated with bipolar disorder.


"Bipolar disorder is a chronic illness with patients experiencing severe debilitating mood swings. Patients spend a majority of their time ill in the depressed phase of the illness. These important findings confirm that SEROQUEL is an effective agent for the treatment of bipolar depression, and particularly encouraging are the results in bipolar II patients who historically have not responded well to treatment," said Professor Alan Young of the Department of Psychiatry, University of British Columbia, Vancouver, Canada.


Results from a combined analysis of all patients with bipolar I or II disorder (n=2593) demonstrated that SEROQUEL monotherapy was significantly more effective than placebo for treating depressive episodes associated with bipolar disorder as measured by improvements in the Montgomery-Зєsberg Depression Rating Scale (MADRS) total score (P

The combined data indicate that SEROQUEL was generally well-tolerated and adverse events were consistent with the known safety profile of quetiapine. The most common adverse events in patients with bipolar disorder were dry mouth, somnolence, sedation, and dizziness. In the subpopulation of patients with bipolar II disorder, the most common adverse events were dry mouth, somnolence, sedation, dizziness, and headache. In the continuation phase of the EMBOLDEN studies, the most common treatment-emergent adverse events with SEROQUEL were headache, somnolence, nasopharyngitis, nausea, diarrhoea, and dry mouth and in the subpopulation of patients with bipolar II disorder were headache, dry mouth, somnolence, nasopharyngitis, dizziness, and nausea.


Similar findings have been observed for SEROQUEL XR, which was approved in the U.S. and Europe in 2008 for the acute treatment of depressive episodes associated with bipolar disorder. In an 8-week study (D144CC00002), SEROQUEL XR 300 mg/day demonstrated significant improvements in MADRS total scores from week 1 though week 8 (both P