New Study Examines SEROQUEL Treatment for
Depressive Episodes Associated with Bipolar Disorder
In the First Large-Scale SEROQUEL study including both Bipolar I and
Bipolar II Disorders, Approximately 50% of Patients taking SEROQUEL achieved
remission from Bipolar Depression Symptoms by Week 2
May 5, 2004 - Wilmington, DE - AstraZeneca (NYSE: AZN) today announced
results from the first large-scale study that examined
SEROQUEL® (quetiapine fumarate) as a treatment for
depressive
episodes that included both patients with
bipolar I and II disorders. Results from this clinical trial suggest
improvement in depressive symptoms for those taking SEROQUEL. Depressive
episodes are characterized by prolonged periods of sadness, unexplained loss of
energy, persistent lethargy and
recurring
thoughts of death or suicide. SEROQUEL is a psychotropic medication approved
for the short-term treatment of acute manic episodes associated with bipolar I
disorder and the treatment of schizophrenia.
This double-blind, placebo controlled trial indicated that patients taking
SEROQUEL had greater improvements in mean MADRS (Montgomery-Asberg Depression
Rating Scale) scores than patients taking placebo (SQL 300mg= -16.7 and SQL
600mg= -16.4 vs. placebo -10.3). These results were seen as early as week one
and continued through week 8. After two weeks, approximately 50% of patients
taking SEROQUEL achieved both a response* and remission** vs. placebo (p<
0.001).
“This study is unique because it is the first to examine SEROQUEL as a
treatment for depressive episodes that included both patients with bipolar I and
bipolar II disorders. These results are an important contribution to the
scientific community,” said Joseph Calabrese, MD, Co-Director of the National
Institute of Mental Health Bipolar Research Center at University Hospitals of
Cleveland and Case Western Reserve University. “Based on these exciting results,
SEROQUEL should be further explored in the area of depressive episodes
associated with bipolar disorder.”
This study of 542 patients who were randomized to receive 8 weeks of
treatment with fixed doses of SEROQUEL (300 mg, 600 mg) or placebo, administered
once-daily, also evaluated anxiety symptoms. Results suggest improvement in
anxiety symptoms at both doses from Day 8 (p<0.05), as measured by the Hamilton
Rating Scale for Anxiety.
“This study is an important step in evaluating the ability of SEROQUEL to
control depressive episodes associated with bipolar disorder,” said Wayne
Macfadden, US Medical Director, AstraZeneca. “AstraZeneca has a clear commitment
to the development of new treatments for mental illness, and is proud of how
successful SEROQUEL has been since its launch in 1997.”
The most commonly observed adverse events associated with the use of SEROQUEL
in this study (>10% and at least twice the placebo rate) were dry mouth,
sedation, somnolence, dizziness and constipation; the tolerability profile is
comparable to that seen in mania trials.
IMPORTANT SAFETY INFORMATION Prescribing should be consistent with the need
to minimize the risk of tardive dyskinesia, seizures, and orthostatic
hypotension. A rare condition referred to as neuroleptic malignant syndrome (NMS)
has been reported with this class of medications, including SEROQUEL. SEROQUEL
is indicated for the
treatment of schizophrenia and the short-term treatment of acute manic
episodes associated with bipolar I disorder. The physician who elects to use
SEROQUEL for extended periods of time should periodically re-evaluate the
long-term usefulness of the drug for individual patients.
There have been reports of diabetes mellitus and hyperglycemia related
adverse events associated with the use of
atypical antipsychotics, including SEROQUEL.
The most commonly observed adverse events associated with the use of SEROQUEL
in clinical trials were somnolence, dry mouth, dizziness, constipation,
asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase,
dyspepsia and weight gain.
Click here for full prescribing information for SEROQUEL, or please visit the
website www.seroquel.com.
ABOUT BIPOLAR DISORDER Bipolar disorder, which affects about 2.3 million
American adults every year, consists of recurring episodes of mania and
depression. Without appropriate treatment, patients with this disorder usually
suffer for a lifetime with periods of wellness and functioning punctuated by
severe episodes of illness. Both men and women are equally at risk for this
illness, which most often emerges in adolescence or young adulthood and recurs
throughout life.
ABOUT ASTRAZENECA 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 $18.8 billion and
leading positions in sales of gastrointestinal, oncology, cardiovascular,
neuroscience and respiratory products. In the United States, AstraZeneca is an
$8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global and European) as well as
the FTSE4Good Index.
Source: AstraZeneca Press Release
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