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Cited by 49Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMental Health Treatment and Access

Symptom Severity and Exclusion From Antidepressant Efficacy Trials

Zimmerman, Mark, Posternak, Michael A., Chelminski, Iwona·2002·Journal of Clinical Psychopharmacology
DOI 10.1097/00004714-200212000-00011
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Abstract

It is the standard practice in antidepressant efficacy trials (AETs) to exclude potential participants with major depressive disorder (MDD) who score below a threshold on the Hamilton Rating Scale for Depression (HAM-D). It is unknown to what extent various cutoff scores impact on the generalizability of these trials. In the present report, we sought to determine how many patients with MDD presenting to an outpatient practice would fail to qualify for an AET because their symptoms were not sufficiently severe, and to what extent the variability in HAM-D cutoff scores impacts exclusion rates. Fifteen hundred individuals presenting for an intake at a psychiatric outpatient practice underwent an evaluation with semistructured diagnostic interviews. Five hundred and three patients received a principal diagnosis of nonbipolar, nonpsychotic MDD. Thirty-nine AETs published in five leading journals during the past 7 years were reviewed, 36 of which required a minimum score on the HAM-D for inclusion. We applied the HAM-D cutoffs used in these AETs to the 503 depressed patients to determine how many would qualify for each AET. Based on the least and most restrictive cutoff scores, between 11.3% and 71.0% of the depressed patients from our practice had an insufficient HAM-D score to qualify for an AET. The two most commonly used cutoff scores would lead to the exclusion of almost half of our sample. AETs tend to include the subset of depressed individuals with moderate to severe MDD and exclude a significant proportion of depressed patients who have mild MDD. The implications of these findings are discussed.

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Authors
Zimmerman, M., Posternak, M. A., & Chelminski, I.
Affiliations
Brown University (US)
ORCID
Zimmerman, Mark
Venue
Journal of Clinical Psychopharmacology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2002-12
Volume
22
Issue
6
Pages
610-614
ISSN
0271-0749 (ISSN-L)
DOI
10.1097/00004714-200212000-00011
OpenAlex
W2333091096
Cited by
49
References
53
Citations by year
2025: 3 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 4 · 2018: 1 · 2017: 1 · 2016: 2 · 2015: 2 · 2014: 4 · 2013: 3 · 2012: 5
FWCI
1.21
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5r29mh048732-05)
  • National Institute of Mental Health (MH48732)
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
Keywords
major depressive disorder, symptom severity, Hamilton Depression Rating Scale, mild depression, generalizability of trial results
MeSH terms
Adult, Antidepressive Agents, Clinical Trials as Topic, Major Depressive Disorder, Female, Humans, Interview, Psychological, Male, Outpatients, Psychiatric Status Rating Scales, Sampling Studies, Severity of Illness Index, Patient Selection

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