MIDAS Project Publication Abstracts
Zimmerman, M., Posternak, M.A., & Chelminski, I. Symptom
severity and exclusion from antidepressant efficacy trials. Journal
of Clinical Psychopharmacology, 2002, 22, 610-614.
It is the standard practice in antidepressant efficacy trials (AETs)
to exclude potential participants with major depressive disorder
(MDD) who score below a threshold on the Hamilton Rating Scale for
Depression (HRSD). It is unknown to what extent various cutoff scores
impact on the generalizability of these trials. In the present report
we sought to determine how many patients with MDD presenting to
an outpatient practice would fail to qualify for an AET because
their symptoms were not sufficiently severe, and to what extent
the variability in HRSD cutoff scores impacts on exclusion rates.
Fifteen hundred individuals presenting for an intake at a psychiatric
outpatient practice underwent an evaluation with semi-structured
diagnostic interviews. Five hundred and three patients received
a principal diagnosis of nonbipolar, nonpsychotic MDD. Thirty-nine
AETs published in five leading journals during the past seven years
were reviewed, 36 of which required a minimum score on the HRSD
for inclusion. We applied the HRSD cutoffs used in these AETs to
the 503 depressed patients to determine how many would qualify for
each AET. Based on the least and most restrictive cutoff scores
between 11.3% and 71.0% of the depressed patients from our practice
had an insufficient HRSD score to qualify for an AET. The two most
commonly used cutoff scores would lead to the exclusion of almost
half of our sample. AETs tend to include the subset of depressed
individuals with moderate to severe MDD, and exclude a significant
proportion of depressed patients who have mild MDD. The implications
of these findings are discussed.
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