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In
the news ...
Antidepressant
drug trials, concerns
Mark Zimmerman, M.D., a clinical researcher at Rhode
Island Hospital, and his team analyzed the criteria used
in antidepressant efficacy studies (AETs) and learned that
the inclusion/exclusion criteria for AETs have narrowed
over the past five years so that the most patients are
excluded.
"The inclusion/exclusion criteria for AETs have narrowed
over the past five years, thereby suggesting that AETs may
be even less generalizable than they were previously,"
said Zimmerman, director of outpatient psychiatry and the
partial hospital program at Rhode Island Hospital and
director of the Rhode Island Methods to Improve Diagnostic
Assessment and Services (MIDAS) project, a study that
integrated researchers' assessment tools and procedures
into a hospital-affiliated outpatient practice.
"More than a decade ago, our
clinical research group raised concerns about the
generalizability of AETs and suggested that the majority
of patients seen in routine clinical practice would not
qualify for an AET," Zimmerman added. "These results were
replicated multiple times. We therefore wondered if drug
companies changed how they recruited patients into
studies. In fact, they have, but in an unexpected way. The
more recent AETs are even less generalizable than the
prior studies, which themselves excluded most depressed
patients from drug company-sponsored treatment studies."
Zimmerman examined 170 placebo-controlled AETs published
during the past 20 years, 56 of which were published
during the past five years.
The more
recent studies were significantly more likely to: 1) exclude patients with comorbid
Axis I disorders and personality disorders; 2) exclude
patients because the episode duration was too
long or too short; and 3) exclude
patients who met diagnostic criteria for major
depression but did not score high enough on a rating
scale.
"For severely
ill patients, such as those who express suicidal thoughts,
it makes ethical sense to exclude them from a study where
they may receive placebos," said Zimmerman. "However,
excluding patients with co-morbid psychiatric disorders
has become more frequent, and patients with any comorbid
Axis I disorder are twice as likely to be excluded in
recent studies. This is important because the majority of
depressed patients have another psychiatric diagnosis. The
exclusion of depressed patients who score too low on
rating scales is the most concerning. This would exclude
approximately half of the patients seen in clinical
practice. In addition, studies have shown that
antidepressants do not work as well for less severely
depressed patients. Thus, drug
companies seem to be stacking the deck to demonstrate
that their products work, even though they might work
only for a narrow segment of depressed patients."
Lifespan. Mayo
Clinic Proceedings
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