Are Subjects in Pharmacological Treatment Trials of Depression Representative of Patients in Routine Clinical Practice?

This study estimated the proportion of depressed patients treated in routine clinical practice who would meet standard exclusion criteria for an efficacy trial. In 346 depressed patients evaluated, it was found that 53, or 15%, would have been excluded from an efficacy trial because they had a bipolar or psychotic subtype of depression. Of the remaining 293 outpatients with nonpsychotic unipolar depression, 252, or 86%, would also have been excluded due to the presence of a comorbid anxiety or substance use disorder, insufficient severity of depressive symptoms, or current suicidal ideation. (26 refs)