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
WILMINGTON, Del. , May 5 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN)
today announced results from the first large-scale study that examined
SEROQUEL(R) (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 (p10% 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. For full prescribing information for SEROQUEL, please visit the website
http://www. seroquel. com. ABOUT BIPOLAR DISORDER
Bipolar disorder, which affects about 2.
buy desyrel online 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. For more information about AstraZeneca, please visit:
http://www. astrazeneca-us. com. * Response rate defined as at least 50% decrease in MADRS from baseline
** Remission defined as MADRS total score <12.
Current Mood:
morose