AstraZeneca - a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services – announced on May 5, 2004, new data from its first large-scale clinical trial to examine Seroquel (quetiapine) as a treatment for depressive episodes in patients with bipolar I and II disorders. The results, presented at the 157th American Psychiatric Association (APA) congress, show that Seroquel is an effective and well-tolerated agent for the treatment of bipolar depression and improves a broad range of anxiety and mood symptoms associated with bipolar depression. Seroquel is currently approved worldwide for the treatment of mania associated with bipolar disorder and schizophrenia. Seroquel has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries. Licenses for bipolar mania have also been received in 23 other countries. Seroquel is the fastest growing product among the three leading brands in the atypical antipsychotic market.
The Bolder study showed that Seroquel was superior to placebo in reducing depressive symptoms, as measured by Montgomery-Asberg Depression Rating Scale (MADRS) scores, in patients with bipolar disorder. Patients treated with Seroquel exhibited a statistically significant improvement across all efficacy measures, including those measuring anxiety, as early as week one. The improvements were noted at every assessment during the eight-week trial. In addition, approximately 50 percent of patients receiving Seroquel achieved remission from their bipolar depression symptoms.
After eight weeks, significantly more patients taking Seroquel achieved remission from their depressive symptoms compared to the placebo group (53 percent vs 28 percent respectively) as evaluated on the MADRS scale. Patients taking Seroquel had significantly greater improvement in mean Hamilton Rating Scale for Anxiety (HAM-A) score versus placebo at every assessment point starting at week one through week eight.
Treatment-emergent mania did not differ between Seroquel and placebo (3 percent vs 4 percent respectively). Significant improvements were also seen on measures of quality of life and quality of sleep at all time points throughout the eight-week study. Bipolar depression and anxiety symptoms were assessed using the MADRS, HAM-D and HAM-A. The primary endpoint for bipolar depression was change in baseline on the MADRS scale.
