Seroquel: New data show efficacy and tolerablity in bipolar depression

May 06, 2004

Alderley Park, England — May 6, 2004 — AstraZeneca announced important new data today presented at the 157th American Psychiatric Association (APA) congress from the 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 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.1,2 SEROQUEL is currently approved worldwide for the treatment of mania associated with bipolar disorder and schizophrenia.

The results of the study show that SEROQUEL was superior to placebo in reducing depressive symptoms, as measured by 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 8-week trial. In addition, approximately 50% of patients receiving SEROQUEL achieved remission from their bipolar depression symptoms.

"This study is unique because it is the first to examine SEROQUEL as a treatment for depressive episodes that included both patients with bipolar I and bipolar II disorders. These results are an important contribution to the scientific community," commented Dr Joseph Calabrese, Co-Director of the National Institute of Mental Health Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University School of Medicine, and lead trial investigator. "Based on these exciting results, SEROQUEL should be further explored in the area of depressive episodes associated with bipolar disorder."

The study, known as the BOLDER study, was a double-blind, placebo controlled trial involving 542 patients with bipolar I and II disorders who were randomised to receive 8 weeks of treatment with either a fixed dose of SEROQUEL (300mg/d, 600mg/d administered once-daily) or placebo. The results of the trial show:1,2

  • Patients taking SEROQUEL achieved a significantly greater improvement (p<0.001) in mean Montgomery-Asberg Depression Rating Scale (MADRS) and Hamilton Rating Scale for Depression (HAM-D) scores versus placebo at every time point starting at week one and through to week 8 (MADRS: -16.7 and -16.4 vs -10.3 in 600mg, 300mg and placebo group, respectively; HAM-D: -13.8 and -13.4 vs -8.5 in 600mg, 300mg and placebo group, respectively).

  • Significantly more patients taking SEROQUEL (p<0.001) were considered responders (≥ 50% decrease from baseline MADRS score) from week 2 through to the end of the study.

  • After 8 weeks significantly more patients taking SEROQUEL achieved remission from their depressive symptoms compared to the placebo group (53% vs 28% respectively, p<0.001) 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 8 (-8.6 and -8.7 vs -5.5; p<0.05 at 600mg, 300mg and placebo, respectively).

  • Treatment-emergent mania did not differ between SEROQUEL and placebo (3% vs 4% respectively).

  • Significant improvements were also seen on measures of quality of life and quality of sleep at all timepoints throughout the 8 week study (p<0.001).

    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.

    Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world.3,4,5,6 More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide.7 A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medication.
    -end-
    SEROQUEL is licensed in Europe and the US for the treatment of mania associated with bipolar disorder. Licences for bipolar mania have also been received in 23 other countries. SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries.

    AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

    In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.

    For more information, please visit www.astrazenecapressoffice.com

    Notes to Editors:
    All product names appear in upper case. SEROQUEL is a trade mark of the AstraZeneca group of companies. SEROQUEL is currently not licensed for the treatment of bipolar depression.

    For further information, please contact:

    Carla Burigatto at AstraZeneca
    Tel: 302-886-5953
    carla.burigatto@astrazeneca.com
    or
    Rebecca Moan at Shire Health International
    Tel: 212-329-6270
    rebecca.moan@shirehealthinternational.com

    For an electronic and downloadable version of this press release or for further information about SEROQUEL, please visit the psychiatry resource internet site at: www.psychiatry-in-practice.com. This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia as well as epidemiological data and treatment issues clinicians face in everyday practice.

    References:
    1 Calabrese J, MacFadden W, McCoy R et al. Double-blind, placebo controlled study of quetiapine in bipolar depression. Abstract presented at APA 2004, NYC, USA.
    2 Calabrese J, MacFadden W, McCoy R et al. Anti-anxiety effects analysis of quetiapine in bipolar depression. Abstract presented at APA 2004, NYC, USA.
    3 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385;395.
    4 Hirschfield et al. Screening for bipolar disorder in the community. J Clin Psychiatry. 2003:64;53-59.
    5Lish JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994:31;281-294.
    6 World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996.
    7 Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guildford Press, 2002.

    Shire Health International

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