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New Patch for Treating Depression
(Source: McMan's
Depression and Bipolar Web, March 1, 2006,
http://www.mcmanweb.com/news.htm)
The FDA has approved
EMSAM (selegiline), a transdermal patch, for the treatment of major
depression. Selegeline is a MAOI originally used to treat
Parkinson's. MAOIs belong to an old class of antidepressants,
typically used as a last resort. When taken orally, side effects with
these meds tend to be onerous, including risk of tyramine reaction and
resulting hypertensive crisis, which necessitates severely restricting
one's diet.
The patch was developed by Somerset Pharmaceuticals, who partnered with
Bristol-Myers Squibb. Because the drug is absorbed through the skin,
there is little or no contact with gastric tyramine and interactions with
various enzymes. Based on three small studies, the product labeling
advises that a modified diet is not required for 6mg a day of EMSAM. But
due to limited data, the labeling advises that those on doses of 9 and
12mg are required to restrict their diets. If hypertensive crisis occurs,
the drug should be discontinued immediately and therapy to lower blood
pressure should be instituted immediately.
EMSAM is contraindicated in use with other antidepressants (including St
John's wort), other MAOIs, and Tegretol and Trileptal, plus a range of
other medicines including cold products and weight-reducing drugs.
The standard suicide warnings found in other antidepressants are repeated
in the EMSAM labeling.
The FDA based its approval on two successful clinical trials. Seven
percent of the patients in the trials dropped out due to an adverse event
(a lower figure than for other antidepressants). The main side effect was
skin irritation where the patch was applied.
Sexual side effects were minimal, but the labeling cautions that no
adequate studies to measure this effect have been performed. Patients
lost a mean of 1.2 pounds over six to eight weeks.
According to a Bristol-Myers Squibb spokesperson, quoted on CNN:
"Our assumption is that psychiatrists are going to be cautious with
this product, but when they're dealing with severe or treatment-resistant
depression, we believe that they will turn to this option."
The
patch is expected to become available at the end of April.
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Study of Minorities with Mood Disorders
Source:
Reintegration Today, Winter 2006, p. 5
University
of Cincinnati (UC) researchers want to determine why African-Americans
seeking help for mood disorders, such as depression or bipolar disorder,
are often misdiagnosed with schizophrenia--putting them at risk of
receiving incorrect treatment.
UC
will lead a four-year multi-center, national study to determine why these
misdiagnoses occur, whether they lead to excessive use of antipsychotic
drugs among African-Americans and whether misdiagnosis are happening in
the Latino population as well.
"Research has already shown that African-American patients are being
improperly diagnosed," said Stephen Strakowski, M.D., professor in
UC's Department of Psychiatry and lead investigator for the study,
"but we need to find out why."
Treatment for mood disorders is different from that typically used for
schizophrenia, Dr. Strakowski pointed out.
"Patients suffering from depression or bipolar disorder who only
receive medications for schizophrenia will continue to experience their
original symptoms," he said, "and they will be at risk for very
poor outcomes.
"Untreated mood disorders result in functional impairment both at
work and in the home. These patients are also at an increased risk
for suicide."
Funded by nearly $10 million from the National Institute of Mental Health
[NIMH], the UC-led study will also include Howard University in
Washington, D.C., the University of California, Los Angeles, the
University of Medicine and Dentistry of New Jersey, the University of
Michigan, and the University of Texas, San Antonio.
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