Recruitment of depressive patients for a controlled clinical trial in a psychiatric practice

Attempts were made to recruit moderately depressed patients to a randomized double-blind study with a new serotonergic-noradrenergic antidepressant in a psychiatry specialist's practice. Although 216 patients consulting a psychiatrist for depression were screened, none were suitable for recruitment into the study. The most common causes of exclusion were severity of depression (n = 199, 92.1%), concomitant treatment with other psychotropic drugs (n = 124, 57.4%) and pre-treatment with an SSRI or MAO-inhibitor (n = 97, 44.9%). On average, there were 3.4 criteria per patient that resulted in exclusion from the study. The difficulties in recruiting patients demonstrate that psychopharmacological studies with the usual inclusion and exclusion criteria are hardly practicable in an office-based psychiatric practice. Furthermore, the question to what extent results from studies performed under restrictive inclusion and exclusion criteria are applicable to routine care must also be put.