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Cited by 223Treatment of Major DepressionMental Health Treatment and AccessAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

Can Phase III Trial Results of Antidepressant Medications Be Generalized to Clinical Practice? A STAR*D Report

Wisniewski, Stephen R., Rush, A. John, Nierenberg, Andrew A., Gaynes, Bradley N., Warden, Diane, Luther, James F., McGrath, Patrick J., Lavori, Philip W., Thase, Michael E., Fava, Maurizio, Trivedi, Madhukar H.·2009·American Journal of Psychiatry
DOI 10.1176/appi.ajp.2008.08071027
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Abstract

OBJECTIVE: Phase III clinical trials for depression enroll participants with major depressive disorder according to stringent inclusion and exclusion criteria. These patients may not be representative of typical depressed patients seeking treatment. This analysis used data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project--which used broad inclusion and minimal exclusion criteria--to evaluate whether phase III clinical trials recruit representative depressed outpatients. METHOD: Of 2,855 participants, 22.2% met typical entry criteria for phase III clinical trials (efficacy sample) and 77.8% did not (nonefficacy sample). These groups were compared regarding baseline sociodemographic and clinical features and the characteristics and outcomes of acute-phase treatment. RESULTS: The efficacy sample had a shorter average duration of illness and lower rates of family history of substance abuse, prior suicide attempts, and anxious and atypical symptom features. Despite similar medication dosing and time at exit dose, the efficacy participants tolerated citalopram better. They also had higher rates of response (51.6% versus 39.1%) and remission (34.4% versus 24.7%). These differences persisted even after adjustments for baseline differences. CONCLUSIONS: Phase III trials do not recruit representative treatment-seeking depressed patients. Broader phase III inclusion criteria would increase the generalizability of results to practice, potentially reducing placebo response and remission rates (reducing the risk of failed trials) but at the risk of some increase in adverse events.

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Crossref · 10.1176/appi.ajp.2008.08071027

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Metadata

Authors
Wisniewski, S. R., Rush, A. J., Nierenberg, A. A., Gaynes, B. N., Warden, D., Luther, J. F., McGrath, P. J., Lavori, P. W., Thase, M. E., Fava, M., & Trivedi, M. H.
Affiliations
University of Pittsburgh (US)
ORCID
Venue
American Journal of Psychiatry
Publisher
American Psychiatric Association Publishing
Published
2009-05
Volume
166
Issue
5
Pages
599-607
ISSN
  • 0002-953X (ISSN-L)
  • 1535-7228
DOI
10.1176/appi.ajp.2008.08071027
OpenAlex
W2124136543
Cited by
223
References
28
Citations by year
2026: 3 · 2025: 2 · 2024: 7 · 2023: 10 · 2022: 8 · 2021: 6 · 2020: 6 · 2019: 10 · 2018: 14 · 2017: 17 · 2016: 14 · 2015: 27 · 2014: 12 · 2013: 12 · 2012: 27
FWCI
17.79
Type
journal article
Language
en
Open access
closed
Locations
  • American Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (n01mh90003-26-0-0)
  • National Institute of Mental Health (N01‐MH‐90003)
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
  • Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords
major depressive disorder, antidepressants, citalopram, STAR*D, trial representativeness, placebo response, remission, response rate, outpatients
MeSH terms
Adult, Demography, Depressive Disorder, Major, Major Depressive Disorder, Drug Administration Schedule, Female, Humans, Male, Practice Patterns, Physicians', Surveys and Questionnaires, Remission Induction, Severity of Illness Index, Time Factors, Citalopram, Selective Serotonin Reuptake Inhibitors, Diagnostic and Statistical Manual of Mental Disorders

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