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BOLDER II Study Confirms Therapeutic Potential of SEROQUEL in Bipolar Depression

Alderley Park, England (ots/PRNewswire)

- For Health Professional Press and Non-UK Journalists Only
Newly released top-line results from the BOLDER II (BipOLar
DEpRession) study have underlined the potential for SEROQUEL
(quetiapine fumarate) in the treatment of patients with major
depressive episodes associated with bipolar disorder. In BOLDER II,
SEROQUEL 300mg and 600mg doses achieved a statistically significant
reduction in levels of bipolar depression compared with placebo
(p<0.001), as measured by the change from baseline in MADRS* total
score(1).
BOLDER II, an eight week, multi-centre, placebo-controlled study,
reinforces the findings of the landmark BOLDER I study(2) published
in  American Journal of Psychiatry in July 2005, which first
indicated a  significant effect for SEROQUEL in treating major
depressive episodes  associated with bipolar disorder.
In BOLDER II, the significant reduction in MADRS total score was
seen both in patients with bipolar I and bipolar II disorder, in
patients with or without a rapid cycling course of illness, and as
early as week one after randomisation. Significant improvements were
also seen compared with placebo in the various secondary study
endpoints among SEROQUEL-treated patients, including reduction of
anxiety symptoms. In addition, more than half (53%) of patients
receiving SEROQUEL achieved remission** from their bipolar depression
symptoms.
Importantly, SEROQUEL was shown to be well tolerated in BOLDER II
with a similar safety profile seen to that in BOLDER I. The rate of
serious adverse events was low and comparable in all treated groups.
The most common adverse events reported in the trial were dry mouth,
sedation, somnolence, dizziness and constipation, and there was a low
incidence of treatment-emergent mania in the SEROQUEL-treated groups.
As in BOLDER I, there was a low incidence of EPS (extrapyramidal
symptoms) and minimal weight change reported in the study.
Professor Joseph Calabrese, co-director of the National Institute
of Mental Health Bipolar Research Center at University Hospitals of
Cleveland and Case Western Reserve University says: "Patients with
bipolar depression are underserved and understudied. The findings
from the BOLDER II study are very encouraging and support the
findings of BOLDER I, in showing the potential of SEROQUEL, as
monotherapy, for the acute treatment for bipolar depression. Each of
these two studies represent the largest placebo-controlled short-term
studies ever conducted in bipolar depression. The beneficial
risk:benefit profile of Seroquel seen in both studies could offer an
important therapeutic value for both patients and physicians as we
currently have only one FDA-approved therapy to treat depressive
episodes associated with bipolar disorder."
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). Patients with bipolar
disorder are symptomatic almost  half of their lives, and
approximately two-thirds of that time is spent in  the depressed
phase of the illness(7). Currently SEROQUEL is only approved  for the
treatment of mania associated with bipolar disorder.
"BOLDER II shows that SEROQUEL may provide substantial clinical
benefits to patients with bipolar disorder", commented Carolyn
Fitzsimons, Seroquel Commercial VP. "Based on prior discussions with
the FDA and the results of BOLDER II, AstraZeneca plans to file for a
US licence extension for SEROQUEL in the treatment of depressive
episodes associated with bipolar disorder around the end of this year
(2005)."
SEROQUEL has been licensed for the treatment of schizophrenia
since 1997 and is available in 85 countries for the treatment of this
condition. SEROQUEL is also licensed in 73 countries for the
treatment of mania associated with bipolar disorder.
* MADRS (Montgomery- Asberg Depression Rating Scale) 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.
** Remission defined as a score of less than 12 on the MADRS scale
(Montgomery-Asberg Depression Rating Scale) at any point in time
during the study
Notes to Editors
All product names appear in upper case. SEROQUEL is a trademark of
the AstraZeneca group of companies.
SEROQUEL is currently not licensed for the treatment of bipolar
depression.
BOLDER II was an eight week, multi-centre, placebo-controlled
trial conducted in the US which evaluated the efficacy of SEROQUEL
(quetiapine) treatment at doses of 300 or 600mg in over 500 patients
with bipolar disorder experiencing major depressive episodes. In
BOLDER, the primary endpoint for bipolar depression was change in
baseline on the MADRS (Montgomery- Asberg Depression Rating Scale).
Bipolar depression and anxiety symptoms were assessed using the
MADRS, HAM-D (Hamilton Rating Scale for Depression) and HAM-A
(Hamilton Rating Scale for Anxiety Scale).
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 over $21.4 billion and leading positions in sales
of gastrointestinal, cardiovascular, respiratory, oncology and
neuroscience products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) 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 and ZOMIG.
SEROQUEL, which has proven efficacy and a very favourable side effect
profile, is the fastest growing of the leading atypical
antipsychotics and the number one prescribed atypical in the United
States with global sales of $2 billion in 2004; ZOMIG is 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, stroke, pain
control and anaesthesia.
Further Information:
For further information, please go to
www.astrazenecapressoffice.com
References:
1. BOLDER II study. AstraZeneca Data on File.
2. Calabrese JR et al. Am J Psychiatry 2005;162:1351-60.
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.
7. Judd, Lll, Akiskal, HS, Schettler, PJ, et al. The long-term
natural history of the weekly symptomatic status of bipolar disorder.
Arch Gen Psychiatry. 2002;59:530-537

Contact:

Louise Marland at AstraZeneca, Tel: +44-(0)-1625-510782, Mobile
+44-(0)7900-607-794, louise.marland@astrazeneca.com; Julie Saunders
at AstraZeneca, Tel: +44-(0)-1625-231319, Mobile:
+44-(0)-7810-528-368, lucy.turvill@hillandknowlton.com

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