Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of...

The inclusion and exclusion criteria used to select subjects for participation in antidepressant efficacy trials (AETs) vary from study to study. It is unknown how much impact different sets of exclusion criteria have on the representativeness of subjects treated in AETs. In the present study, we applied the inclusion and exclusion criteria used in 39 recently published AETs to patients evaluated in routine clinical practice to evaluate the range and extent of the representativeness of samples treated in AETs. Nearly 600 patients with DSM-IV major depressive disorder (MDD) or bipolar depression underwent a thorough diagnostic evaluation. Inclusion and exclusion criteria used in AETs were applied to determine how many patients from our sample would have qualified for each AET had they applied. Approximately one sixth of the 596 depressed patients would have been excluded from an efficacy trial because they had a bipolar or psychotic subtype of depression. In the remaining 503 outpatients with nonpsychotic, unipolar MDD, the rates of exclusion ranged from 0% to 95.0% (mean=65.8%). Thus, the findings suggest that there is much variability in the generalizability of AETs, although, in general, subjects treated in AETs represent only a minority of patients treated for MDD in a community-based psychiatry outpatient practice.