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Monday 24th October, 2005
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Seroquel achieved a statistically significant reduction in levels of bipolar
depression when compared with placebo.
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Alderley Park, Cheshire, UK: - 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 study2 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.
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As in BOLDER I, there was a low incidence of EPS (extrapyramidal
symptoms) and minimal weight change reported in the study.
* MADRS (Montgomery- ?berg 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
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.
###
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- ?berg 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).
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.
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