Generalizability of Clinical Trial Results for Major Depression to Community Samples: Results From the National Epidemiologic Survey on Alcohol and Related Conditions
J Clin Psychiatry 2008;69(8):1276-1280
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: Although emerging data
indicate that sample composition may influence the
effectiveness of mental health interventions, the
extent to which subjects in clinical trials represent
affected community samples remains unknown. The goal of this study was to assess the
proportion of community-dwelling adults with major depressive episode (MDE) who would meet
eligibility criteria for a traditional efficacy trial in
patients with MDE.
Method: We applied a standard set of
exclusion criteria used in clinical trials in
patients with MDE to the 2001-2002 National
Epidemiologic Survey for Alcohol and Related
Conditions (NESARC), the largest psychiatric
epidemiologic study in the United States to date (N =
43,093). Because individuals who seek treatment for
a disorder may systematically differ from those who do not, we applied the criteria first to all
individuals with a current diagnosis of MDE (N = 3119) (diagnosed according to DSM-IV) and
then to the subsample of individuals who sought
treatment (N = 1359).
Results: Among the full sample of
individuals with MDE, 75.8% were excluded by one or
more study eligibility criteria. Approximately two thirds (66.9%) of the subsample of those
who sought treatment were excluded. The percentage of subjects excluded by individual study
criteria ranged from 2.4% to 47.4% in the overall
sample and 0% to 38.4% in the treatment-seeking sample. For both groups, the presence of
comorbid, nondepressive, non-substance use Axis I
disorders and the duration of the depressive
episode excluded the largest percentage of individuals.
Conclusion: The design of traditional
clinical trials tends to exclude a majority of
individuals with MDE. Selection of exclusion criteria
may have a powerful influence on the
generalizability of study results. Clinical trials should explain
the rationale for their exclusion criteria and
estimate the impact of eligibility criteria on the
generalizability of trial results.