you really ever believe a study of psychotropic drugs done by the company
that
owns the patent on the drug? ; I hope not, because, chances are, your doctor
will. You see, if the drug company can get the FDA to approve a
"new" usage, they get a new patent. Convenient, isn't it. Now everyone who
gets an SSRI/SNRI will get Seroquel, too. --Catherine]
Studies Examine Quetiapine Fumarate in Combination With Antidepressant
Therapy in Patients With Depression
WILMINGTON, D.E. -- May 30 2006 -- AstraZeneca announced results of two
clinical studies that examined Seroquel(R) (quetiapine fumarate) in
combination with antidepressant therapy in patients with depression.
One study evaluated the use of Seroquel in combination with antidepressant
therapies (SSRI/SNRI medications(+)) to improve residual depressive and
anxiety symptoms in patients with major depressive disorder.(1) Another
study examined the benefit of Seroquel when added to SSRI/SNRI therapies in
patients with treatment-resistant depression.(2)
These two studies were presented at the annual meeting of the American
Psychiatric Association (APA).
Seroquel is approved for the treatment of acute manic episodes associated
with bipolar I disorder and the treatment of schizophrenia. On December 30,
2005, AstraZeneca submitted a supplemental New Drug Application (sNDA) with
the U.S. Food and Drug Administration (FDA) to seek approval for Seroquel in
the treatment of patients with depressive episodes associated with bipolar
disorder. Seroquel is currently being investigated for the treatment of
major depressive disorder.
"There is growing evidence that augmentation of antidepressant therapy with
atypical antipsychotics may help improve symptoms of depression," said Greg
Mattingly, M.D., Associate Clinical Professor, Department of Psychiatry,
Washington University School of Medicine. "These studies are encouraging and
warrant further investigation of the potential of Seroquel(R) (quetiapine
fumarate), both as a monotherapeutic agent as well as in the augmentation of
SSRI/SNRI therapy, in patients with major depressive disorder."
About the Studies
One study was a double-blind, randomized placebo-controlled trial designed
to evaluate Seroquel augmentation of SSRIs/SNRIs in patients with residual
depressive and prominent anxiety symptoms associated with major depression.
In this study, patients (n=58) with residual symptoms following at least six
weeks of SSRI/SNRI treatment received Seroquel (50-600mg/day; mean dose=202
mg/day) or placebo for eight weeks.(1)
The study found significant reduction (Seroquel vs. placebo) in several
rating scales as early as week 1 (p less than or equal to 0.01) and
continuing through week 8 (p less than or equal to 0.01). HAM-D(++) results
for Seroquel at week 1 and week 8 vs. placebo at week 1 and week 8 were -6.5
and -11.2 vs - 2.9 and -5.5; HAM-A (S) (-7.4, -12.5 vs -3.4, -5.9);
CGI-Severity** (-0.45, -1.5 vs -0.07, -0.6).(1)
The second trial, also a randomized, double-blind, placebo-controlled trial
(n=39), examined augmentation of Seroquel (200-400 mg/day; mean dose=268
mg/day) to SSRI/SNRI therapy in treatment-resistant depression. At the end
of the eight-week trial, patients receiving Seroquel(R) (quetiapine
fumarate) had significantly lower HAM-D17 scores versus placebo (8.3 vs.
14.7, respectively, P <.01). Additionally, significantly more patients
receiving Seroquel demonstrated a response to treatment (greater than or
equal to 50% reduction in HAM-D17 score) (67% vs. 27%, P =.015), and
achieved remission (HAM-D17 score <7) (43% vs. 15%, P <.05), versus
placebo.(2)
The most common adverse events observed in these trials include sedation,
somnolence, lethargy, dry mouth, weight gain, dizziness, headache, similar
to previous clinical trials of Seroquel.(1,2)
"AstraZeneca recognizes the difficulties in treating depression and is
dedicated to finding new therapies and regimens for patients who suffer from
this disorder," adds Wayne Macfadden, M.D., US Medical Director for
Seroquel. "The results of these analyses reinforce the importance of
additional investigation of the potential role of Seroquel in managing
symptoms associated with depression."
The studies were conducted by A. McIntyre and associates at the Department
of Psychiatry of Penticton Regional Hospital in Penticton, British Columbia,
Canada and Gregory W. Mattingly and associates at Washington University
School of Medicine. Both studies were supported by AstraZeneca
Pharmaceuticals.
Seroquel is the #1 prescribed atypical antipsychotic in the United
States.(3) With a well-established safety and efficacy profile, Seroquel has
had more than 16 million patient exposures worldwide since its launch in
1997. In 2005, global sales for Seroquel reached $2.8 billion.
Important Safety Information
Seroquel(R) (quetiapine fumarate) is indicated for the treatment of acute
manic episodes associated with bipolar I disorder, as either monotherapy or
adjunct therapy with lithium or divalproex, and the treatment of
schizophrenia. Patients should be periodically reassessed to determine the
need for continued treatment. It is recommended Seroquel be taken twice
daily in divided doses. Seroquel is not currently approved for the treatment
of major depressive disorder or the depressive phase of bipolar disorder.
Elderly patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death
compared to placebo (4.5% vs 2.6%, respectively). Seroquel is not approved
for the treatment of patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of
tardive dyskinesia. A rare condition referred to as neuroleptic malignant
syndrome has been reported with this class of medications, including
Seroquel.
Hyperglycemia, in some cases extreme and associated with ketoacidosis,
hyperosmolar coma or death, has been reported in patients treated with
atypical antipsychotics, including Seroquel. Patients starting treatment
with atypical antipsychotics who have or are at risk for diabetes should
undergo fasting blood glucose testing at the beginning of and during
treatment. Patients who develop symptoms of hyperglycemia should also
undergo fasting blood glucose testing.
Precautions include the risk of seizures, orthostatic hypotension, and
cataract development.
The most commonly observed adverse events associated with the use of
Seroquel in clinical trials for schizophrenia and bipolar mania were
somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain,
postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight
gain.
+ Selective serotonin reuptake inhibitors (SSRIs) act specifically on the
neurotransmitter serotonin. These medications include fluoxetine (Prozac),
sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa) and
escitalopram (Lexapro). Serotonin and norepinephrine reuptake inhibitors
(SNRIs) are useful as first-line treatments in people taking an
antidepressant for the first time and for people who have not responded to
other medications. These medications include Venlafaxine (Effexor).(4) |