|
|
BY OUR PHARMA CORRESPONDENT 24
April,2007: Drugs currently in use to
stabilize mood swings in bipolar disorder may not
be of much help.
Bipolar disorder (BD), a sometimes debilitating
illness marked by severe mood swings between
depression and mania, is usually treated with mood
stabilizers such as lithium, valproate,
carbamazepine or other medications that reduce
mania.
For depressed people with bipolar disorder who are
taking a mood stabilizer, adding an antidepressant
medication is no more effective than a placebo
(sugar pill), according to results published
online on March 28, 2007 in the "New England
Journal of Medicine".
"Treating depression in people with bipolar
disorder is notoriously difficult," said the
National Institutes of Health's National Institute
of Mental Health (NIMH) Director Thomas R. Insel.
The results are part of the large-scale,
multi-site Systematic Treatment Enhancement
Program for Bipolar Disorder (STEP-BD), a $26.8
million clinical trial funded by NIMH. STEP-BD
sought to determine if adding an antidepressant to
a mood stabilizer is effective and safe in
treating depressive episodes. The results suggest
that antidepressants are safe but not more
effective than placebo as assessed in a large
number of people with bipolar disorder.
However, depression is more common than mania in
bipolar disorder, and depressive episodes tend to
last longer than episodes of mania. Antidepressant
medications are often used in addition to a mood
stabilizer for treating bipolar depression, but
they are thought to confer a serious risk of a
switch from a depressive episode to a manic
episode.
Finding the right treatment balance for people
with bipolar disorder is a constant challenge;
STEP-BD aims to identify the best treatment
options.
Lead author Gary Sachs, M.D., of Massachusetts
General Hospital and colleagues studied 366
participants at 22 sites across the country.
Unlike most clinical studies, participants were
recruited from clinical settings and were included
in the study even if they were being treated for
co-existing disorders such as substance abuse,
anxiety or psychotic symptoms. Such open
recruitment criteria allows the study's results to
have broader applicability than a tightly
controlled trial in which people are excluded from
participating if they have co-existing disorders.
Before participants were randomized to one of two
antidepressants -- bupropion (Wellbutrin) or
paroxetine (Paxil) -- or to a placebo, doctors
trained in the treatment of bipolar disorder
adjusted participants' mood stabilizer doses to
optimal levels, ensuring that they were receiving
the most appropriate amount.
After about 26 weeks, Sachs and colleagues found
that 24 percent of those who had been randomized
to the antidepressants stayed well for at least
eight consecutive weeks -- the study's stringent
standard for recovery; 27 percent of those
randomized to a placebo stayed well long enough to
meet the eight-week recovery standard, indicating
no difference between adding an antidepressant or
adding placebo. In addition, about 10 percent of
each group experienced emerging symptoms of mania,
indicating that the antidepressants did not
trigger a manic switch any more than placebo.
Finally, when comparing the two antidepressants to
each other, both showed similar rates of response
and manic switch.
"Results of STEP-BD indicate that careful
management of mood stabilizer medications is a
reasonable alternative to adding an antidepressant
medication for treating bipolar depression," said
Dr. Sachs.
Future STEP-BD results will shed light on other
treatment options for bipolar disorder, including
psychotherapeutic treatments.
The National Institute of Mental Health (NIMH)
mission is to reduce the burden of mental and
behavioral disorders through research on mind,
brain, and behavior.
BY OUR PHARMA CORRESPONDENT |
