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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 www.astrazeneca.com or
www.astrazenecapressoffice.com. Further information is also available
at the psychiatry resource internet site
www.psychiatry-in-practice.com.
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.
References
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.

Contact:

Contact: Louise Marland, AstraZeneca, Tel : +44-1625510782 (office)
or Mobile: +44-(0)-7919-565988, Email:
louise.marland@astrazeneca.com; Sarah Winkless, Hill & Knowlton, Tel:
+44-(0)20-7413-3204, Mobile: +44-(0)7771-757695, Email:
sarah.winkless@hillandknowlton.com ; Karine Jegard, Hill & Knowlton,
Tel: +44-(0)20-7413-3052, Mobile: +44-(0)7771-596959, Email:
kjegard@hillandknowlton.com

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