The data from the study show SEROQUEL to be significantly more effective than placebo and well tolerated for the treatment of anxiety symptoms in bipolar depression. Furthermore, the data show that SEROQUEL works quickly to reduce the symptoms of anxiety, having a significant effect on symptoms within the first week of treatment and continuing to improve symptoms throughout the 8 weeks of treatment.1
These new data presented today are from the large-scale, multi-centred, BOLDER trial presented last month at the157th American Psychiatric Association (APA) meeting, which found SEROQUEL to be an effective and well-tolerated agent for the treatment of depressive symptoms associated with bipolar disorder.2
"Many patients with bipolar depression experience intense anxiety, and sometimes this is more disturbing than the depressive symptoms. Symptoms of anxiety are known to be associated with suicide attempts in bipolar disorder. Indeed, anxiety symptoms are frequently the reason why patients seek treatment in the first place.
Therefore, it is important for medications that work in bipolar depression to be effective treatments for anxiety, and that they work quickly and effectively," 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. "These data demonstrate that with SEROQUEL, psychiatrists have a potential new treatment for bipolar depression, that is effective and works quickly for both depression and anxiety symptoms."
The BOLDER trial was an 8 week, multi-centred, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of bipolar I or II disorder. Patients received 300mg/day SEROQUEL or 600mg/day SEROQUEL, or placebo. The results of this trial showed:
- Patients taking SEROQUEL 600 mg/day and 300mg/day had a significantly greater improvement (p<0.05) in mean Hamilton Rating Scale for Anxiety (HAM-A) score versus placebo at every assessment point from week one through to week 8 (-8.75, -8.64 vs -5.5).
- Patients receiving SEROQUEL experienced a broad improvement across most items of the HAM-A scale. Significant improvement was observed after 8 weeks treatment in the following items: anxious mood, depressed mood, insomnia (p<0.001 for SEROQUEL 300mg/day and 600mg/day); tension (p<0.01 for SEROQUEL 300mg/day and 600mg/day); intellect and behaviour at interview (p<0.05 for SEROQUEL 300mg/day subgroup, for both items).
- SEROQUEL was well tolerated with no significant increase in extrapyramidal symptoms (EPS) including akathisia at either dose and a favourable weight profile which was noted in all three treatment groups.
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 Anxiety is commonly experienced in patients with mood disorders such as bipolar disorder and can be identified by a number of different distressing symptoms, that often encourage people to seek treatment for their condition.7 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.8 A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medication.
SEROQUEL is licensed in 35 countries for the treatment of mania associated with bipolar disorder, including the US and several European countries. SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries. To date, over 4 million people have been treated with SEROQUEL worldwide.
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.
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 and is not registered in France.
For further information, please view a webcast on this data being broadcast from the CINP meeting on http://www.astrazenecapressoffice.com or please contact:
For an electronic and downloadable version of this press release or for further information about SEROQUEL, please visit the psychiatry resource internet site at: http://www.psychiatryinpractice.com. This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia and bipolar disorder as well as epidemiological data and treatment issues clinicians face in everyday practice.
References
1. Macfadden W, Calabrese J, McCoy R et al. Anti-anxiety effects analysis of quetiapine in bipolar depression. Abstract presented at CINP, Paris, 2004.
2. 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.
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.
5. Lish 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.