How Many Subjects With Major Depressive Disorder Meet Eligibility Requirements of an Antidepressant Efficacy Trial?
J Clin Psychiatry 2003;64(9):1091-1093
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: To evaluate the generalizability of
the results of antidepressant efficacy trials by determining how
many subjects with DSM-IV major depressive disorder who apply for
entry into such trials are ultimately enrolled.
Method: The screening results of 378 subjects
who inquired about participating in 1 of 2 separate
antidepressant efficacy trials performed at Rhode Island Hospital
between 1997 and 2002 were reviewed. The number of subjects who
enrolled, as well as the reasons for exclusion of those who did
not meet eligibility requirements, were determined.
Results: Of the 378 inquiries, 186 subjects
expressed interest and received a current major depressive
disorder diagnosis. From this sample, 27 (14.5%) were ultimately
enrolled in 1 of the 2 antidepressant trials. The most common
reasons for exclusion were bipolar disorder (17.2%), drug or
alcohol abuse (15.6%), mild depression (14.0%), medical
contraindication (12.9%), and the use of prohibited psychotropic
Conclusion: The majority of subjects with major
depressive disorder who apply to participate in an antidepressant
efficacy trial do not meet eligibility requirements. When
prescribing antidepressants, clinicians should bear in mind that
the results of these trials may only be directly applicable to a
small subset of patients treated in clinical practice.