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18.09.2006 – 14:19

AstraZeneca GmbH

New Data Offers Hope to Patients With Bipolar Disorder and Schizophrenia

    Paris (ots/PRNewswire)

    - For Healthcare and Medical Reporters (non-US)

    Bipolar disorder is the sixth largest cause of disability worldwide in people aged 15-44 years[1] and is commonly mistaken for other diseases such  as acute depression. Consequently, people may suffer with symptoms for years before receiving appropriate treatment and up to half of all individuals with bipolar disorder may make at least one suicide attempt in their lifetime[2].

    Data presented at the 19th European College of Neuropsychopharmacology in Paris has highlighted the significant impact of this disease and demonstrated the efficacy of an 'atypical' antipsychotic known as quetiapine (SEROQUEL). From the first week of the BOLDER II (BipOLar DEpRession) study, improvements in the severity of depressive symptoms (MADRS total scores[x]) were significantly greater with quetiapine 300 and 600 mg/d than with placebo (week 1, change from baseline with quetiapine 300 and 600 mg/d: -9.42 and -9.14, respectively; both P<0.001 vs placebo: -6.10) and the improvements continued during the eight week study (week 8, change from baseline with quetiapine 300 and 600 mg/d: -16.94 and -16.00 respectively; both P<0.001 vs placebo: -11.93. In BOLDER II 509 patients were randomized to treatment and 59% completed the study[3].

    A further study highlighted how the adoption of rating scales[xx] in key trials which tested for both the manic and depressive aspects of the condition showed that quetiapine significantly improved many clinically relevant symptoms[4]. Two placebo-controlled trials of quetiapine monotherapy in 403 patients experiencing manic symptoms of disorder demonstrated that when treating mania in patients with bipolar disorder, clinically relevant symptoms improved by day four with a further improvement on day eight for those patients suffering with depression[4]

    "Bipolar disorder is a seriously debilitating disease for many people which, sadly, sometimes resulting in suicide. Currently there is no monotherapy which treats both the manic and depressive episodes of this condition. Physicians have traditionally treated bipolar disorder with both a mood stabilizer and an antidepressant. Having a single medication to treat both the manic and depressive episodes would be a significant medical advance." said Dr Joseph R Calabrese, MD, Case Western Reserve University, University Hospitals of Cleveland, Cleveland, Ohio, USA

    People with bipolar disorder experience swings of mood from periods of feeling overly 'high' or euphoric (called 'mania' or 'manic episodes'), to periods of sadness and hopelessness (depression), and then back again, often with periods of normal mood ('euthymia') in between. Bipolar disorder typically begins in late adolescence or early adulthood (between the ages of 15 and 24 years) and episodes of mania and depression usually recur throughout the person's life which has a significant impact on a person's quality of life.

    In addition to the results in bipolar disorder a study of SEROQUEL (quetiapine) in patients with schizophrenia was recently published in the September issue of the International Journal of Psychiatry in Clinical Practice[5] demonstrating that treatment with SEROQUEL led to a significant reduction in disease severity and an improvement in patients' subjective well-being of approximately 40%. SEROQUEL was well tolerated and more efficacious than previous medication.

    The study was one of the few to investigate the subjective well-being  of patients, reflecting their normality of function and feeling[7]. Patients' subjective response to therapy is influenced by a number of factors including, their attitudes and values, their own view of their illness and general health as well as any previous experiences medication [6,8]. Their experience with medication has a major effect on long-term adherence, which can have implications for relapse and long term clinical outcomes[9]. The authors conclude that the improvements shown with SEROQUEL, together with the favourable tolerability profile of SEROQUEL may lead to increased treatment adherence and ultimately improved patient outcomes.

    Quetiapine (quetiapine fumarate) has a well-established safety and efficacy profile and to date over 16 million people have been treated with quetiapine worldwide. Quetiapine has been licensed for the treatment of schizophrenia since 1997 and it is available in 85 countries for the treatment of this condition. Quetiapine is also licensed in 73 countries for the treatment of mania associated with bipolar disorder. SEROQUEL(R) (quetiapine) is marketed by AstraZeneca and it is the number one prescribed atypical antipsychotic in the United States, with global sales of US$2.8 billion in 2005.

    In December 2005, AstraZeneca submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval for a new indication for SEROQUEL(R) for the treatment of patients with depressive episodes associated with bipolar disorder.

    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 world's leading pharmaceutical companies with healthcare sales of US$23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

    For further information, please visit or Further information is also available at the psychiatry resource internet site

    Notes to Editors:

    BOLDER I & BOLDER II are both eight week, multi-centre, double-blind placebo-controlled studies. Outpatients with both bipolar I and II disorder were randomised to receive eight weeks' treatment with 300mg or 600mg SEROQUEL or placebo, administered once daily.

    [x] Depression scores were measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), which measures the severity of a number of depressive symptoms including mood and sadness, tension, sleep, appetite, energy, concentration, suicidal ideation and restlessness. The MADRS score decreases as depression symptoms improve.

    [xx] The rating scales included the Young Mania Rating Scale (YMRS) which looked at speech rate and amount, appearance, motor activity/energy, sleep and language thought disorder including sexual interest, elevated mood and irritability/disruptive or aggressive behaviour.


    1. Woods SW. J Clin Psychiatry. 2000;61(suppl 13):38-41.

    2. Goodwin FK, Jamison KR. New York, NY: Oxford University Press; 1990:416-502.

    3. Thase M, Macfadden W, McCoy, R, Chang W, Calabrese JR. Quetiapine monotherapy is efficacious for depressive episodes of bipolar I and II disorder: A confirmatory double-blind study (BOLDER II) Poster presented at the European Congress of Neuropsychopharmacology, Paris 2006

    4. Ketter A. Rates of improvement with quetiapine across dimensions of bipolar disorder. J Eur College of Neuropsychopharmacology 2006; Vol 16: 4: S356

    5. Lambert M, Reimitz PE, Naber D. Effectiveness, tolerability and subjective well-being in patients receiving quetiapine:dindings of a post-marketing surveillance study in schizophrenia. Int J Psych in Clin Prac 2006; 10(3):204-212

    6. Carrick R, Mitchell A, Powell RA, et al. The quest for wellbeing: A qualitative study of the experience of taking antipsychotic medication. Psychol Psychother 2004;/77:/19-33.

    7. Lambert M Schimmelmann BG, Karow A, et al. Subjective well-being and initial dysphoric reaction under antipsychotic drugs _/ Concepts, measurement and clinical relevance. Pharmacopsychiatry 2003;/36(Suppl 3):/181-90.

    8. Rogers A, Day JC, Williams B, et al. The meaning and management of neuroleptic medication: a study of patients with a diagnosis of schizophrenia. Soc Sci Med 1998;/47:/ 1313-23.

    9. Lacro JP, Dunn LB, Dolder CR, et al. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: A comprehensive review of recent literature. J Clin Psychiatry 2002;/63:/892-909.

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