10003636 J Clin Psychiatry / Document Archive

Psychiatrist.com Home    Keyword Search

Close [X]

Search Our Sites

Enter search terms below (keywords, titles, authors, or subjects). Then select a category to search and press the Search button. All words are assumed to be required. To search for an exact phrase, put it in quotes. To exclude a term, precede it with a minus sign (-).

Keyword search:

Choose a category:

Choosing the appropriate category will greatly improve your chances of finding the best match.

All files at our sites: J Clin Psychiatry, Primary Care Companion, CME Institute, and MedFair

Search materials from our journals:

Abstracts from The Journal of Clinical Psychiatry, 1996–present, both regular issues and supplements

PDFs of the full text of The Journal of Clinical Psychiatry, 1996–present, both regular issues and supplements (Net Society Platinum [paid subscribers])

PDFs of the full text of The Primary Care Companion to The Journal of Clinical Psychiatry, 1999–present

Search CME offerings:

CME Institute, including CME from journals , supplements, and Web activities for instant CME credit (Net Society Gold [registered users]); also includes information about our CME program

CME activities from regular issues of The Journal of Clinical Psychiatry (Net Society Gold [registered users])

CME Supplements from The Journal of Clinical Psychiatry (Net Society Gold [registered users])


The article you requested is

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;69:1276-1280
Copyright 2008 Physicians Postgraduate Press, Inc.

To view this item, select one of the options below.

    1. Purchase this PDF for $40
      If you are not a paid subscriber, you may purchase the PDF.
      (You'll need the free Adobe Acrobat Reader.)
    2. Subscribe
      Receive immediate full-text access to JCP. You can subscribe to JCP print + online for $166 individual.
      JCP's 75th AnniversaryCelebrate!
      Celebrate JCP's 75th Anniversary with a special online-only subscription price of $75.
    1. Activate
      If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
    2. Sign in
      As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
  1. Did you forget your password?

Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send an email


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.