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
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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“Results from a large trial conducted in a clinical setting (the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial) showed that 77.8% of the patients in the STAR*D trial would have been excluded in conventional clinical trials.”
From Should antidepressants be used for major depressive disorder? (2020) · cites this paper as [42]
Citations
Cites
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Self-citationTrivedi, M. H., Rush, A. J., Wisniewski, S. R., Nierenberg, A. A., Warden, D., Ritz, L., Norquist, G., Howland, R. H., Lebowitz, B., McGrath, P. J., et al. (2006) · American Journal of Psychiatry · doi:10.1176/appi.ajp.163.1.28 · Cited by 3,879
Self-citationRush, A. J., Trivedi, M. H., Ibrahim, H. M., Carmody, T. J., Arnow, B., Klein, D. N., Markowitz, J. C., Ninan, P. T., Kornstein, S., Manber, R., et al. (2003) · Biological Psychiatry · doi:10.1016/s0006-3223(02)01866-8 · Cited by 3,829
Self-citationExternal validity of randomised controlled trials: “To whom do the results of this trial apply?”
Rothwell, P. M. (2005) · The Lancet · doi:10.1016/s0140-6736(04)17670-8 · Cited by 2,544
CUMULATIVE ILLNESS RATING SCALE
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The Inventory of Depressive Symptomatology (IDS): Psychometric properties
Rush, A. J., Gullion, C. M., Basco, M. R., Jarrett, R. B., & Trivedi, M. H. (1996) · Psychological Medicine · doi:10.1017/s0033291700035558 · Cited by 2,177
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Sequenced treatment alternatives to relieve depression (STAR*D): Rationale and design
Rush, A. J., Fava, M., Wisniewski, S. R., Lavori, P. W., Trivedi, M. H., Sackeim, H. A., Thase, M. E., Nierenberg, A. A., Quitkin, F. M., Kashner, T. M., et al. (2004) · Controlled Clinical Trials · doi:10.1016/s0197-2456(03)00112-0 · Cited by 1,076
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Kennedy-Martin, T., Curtis, S., Faries, D., Robinson, S., & Johnston, J. (2015) · Trials · doi:10.1186/s13063-015-1023-4 · Cited by 878
“…overall functioning/ SES Different Talamo et al., 2008 [63] SC-PR 77.6 Few differences Similar van der Lem et al., 2011 [64] SC-PR 75.5–81.2e ND NE Wisniewski et al., 2009 [47] MC-PR 77.8 Older, less educated, more black/Hispanic, longer disease duration, history of suicide and substance abuse,…”
BackgroundInfluentialHyde, C. L., Nagle, M. W., Tian, C., Chen, X., Paciga, S. A., Wendland, J. R., Tung, J. Y., Hinds, D. A., Perlis, R. H., & Winslow, A. R. (2016) · Nature Genetics · doi:10.1038/ng.3623 · Cited by 784
O’Connor, E., Rossom, R. C., Henninger, M., Groom, H. C., & Burda, B. U. (2016) · JAMA · doi:10.1001/jama.2015.18948 · Cited by 563
Fu, C. H. Y., Steiner, H., & Costafreda, S. G. (2013) · Neurobiology of Disease · doi:10.1016/j.nbd.2012.05.008 · Cited by 399
“However, in most cases, efficacy needs to be evaluated after 6 to 12 weeks of treatment, and a large proportion of patients have persistent symptoms despite a full treatment trial (Wisniewski et al., 2009).”
BackgroundCarpenter, L. L., Janicak, P. G., Aaronson, S. T., Boyadjis, T. A., Brock, D. G., Cook, I. A., Dünner, D. L., Lanocha, K. I., Solvason, H. B., & Demitrack, M. A. (2012) · Depression and Anxiety · doi:10.1002/da.21969 · Cited by 371
“Retrospective analysis of the STAR*D data done with the study population stratified according to conventional enrollment criteria for a phase III clinical trial found that the subset of patients meeting these criteria had relatively shorter durations of illness and lower rates of family history of substance abuse, pri…”
Method
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
- Published
- 2009-05
- Volume
- 166
- Issue
- 5
- Pages
- 599-607
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- 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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