MIDAS Project Publication Abstracts
Zimmerman, M., Mattia, J.I. & Posternak, M.A. Are subjects
in pharmacological treatment trials of depression representative
of patients in routine clinical practice. American Journal
of Psychiatry, 2002, 159, 469-473.
Objective: The methods used in studies establishing the efficacy of
antidepressant medications are at variance from how depression is treated
in routine clinical practice. In particular, the rigorous inclusion and
exclusion criteria used to select subjects for participation in efficacy
studies potentially limits the generalizability of the results of these
trials. It is currently unknown how much impact these inclusion and
exclusion criteria have on the representativeness of subjects treated in
efficacy trials. The goal of the present study was to determine how many
depressed patients treated in routine clinical practice would meet
standard inclusion and exclusion criteria for an efficacy trial. Method:
Eight hundred and three individuals aged 16 to 65 presenting for an intake
appointment at a general psychiatric outpatient practice underwent a
thorough diagnostic evaluation that included the administration of
semi-structured diagnostic interviews. Three hundred forty-six patients
had a current major depressive episode. Common inclusion and exclusion
criteria used in efficacy studies of antidepressants were applied to the
depressed patients to determine the percentage that would have qualified
for an efficacy trial. Results: Approximately one-sixth of the 346
depressed patients would have been excluded from an efficacy trial because
they had a bipolar or psychotic subtype of depression. In the remaining
293 outpatients with nonpsychotic, unipolar major depressive disorder, the
presence of a comorbid psychiatric disorder, insufficient severity of
depressive symptoms, or current suicidal ideation would have excluded
86.4% of patients from an antidepressant efficacy trial.
Conclusions: Subjects treated in efficacy trials of antidepressant
medications represent only a small minority of patients treated for major
depressive disorder in a routine clinical psychiatry practice. These
results highlight that antidepressant efficacy trials tend to evaluate a
small subset of depressed individuals with a very specific clinical
profile. The implications of these findings are discussed.
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