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Cited by 55Treatment of Major DepressionStatistical Methods in Clinical TrialsPsychometric Methodologies and Testing

Fewer study participants needed to demonstrate superior antidepressant efficacy when using the Hamilton melancholia subscale (HAM-D 6 ) as outcome measure

Østergaard, Søren Dinesen, Bech, Per, Miskowiak, Kamilla Woznica·2016·Journal of Affective Disorders
DOI 10.1016/j.jad.2014.10.047
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Abstract

Background In the development of new antidepressant treatments, the failed study has unfortunately become a prevalent problem. The number of failed studies could probably be reduced significantly by applying more informative outcome measures. Previous studies have indicated that the 6-item melancholia subscale (HAM-D6) of the 17-item Hamilton Depression Rating Scale (HAM-D17) may be more informative than other scales, due to its superior psychometric properties. In the present study we investigated whether the HAM-D6 had higher informativeness than the HAM-D17 based on data from a randomized placebo-controlled trial (RCT) testing the effect of erythropoietin (EPO) as augmentation therapy in patients with treatment-resistant depression.Methods We assessed the scalability (Mokken analysis of unidimensionality), responsiveness (item responsiveness analysis) and ability to show drug-placebo separation (estimation of sample size needed to detect statistically significant difference between EPO and placebo) of the HAM-D6 and the HAM-D17.Results The HAM-D6 demonstrated higher scalability, higher responsiveness, and better drug-placebo separation compared to the HAM-D17. As a consequence, only 39 participants per group would be required to detect a statistically significant difference between EPO and placebo when using the HAM-D6 as outcome measure, whereas the required group size for HAM-D17 would be 146 participants.Limitations The EPO RCT was not originally designed to investigate the research questions addressed in this study.Conclusions Both for ethical and financial reasons it is of interest to minimize the number of participants in clinical trials. Therefore, we suggest employing the HAM-D6 as outcome measure in clinical trials of depression.

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  • The concept of remission provides only a vague theoretical definition that may be influenced by the psychometric limitations of available instruments.

    “However, the concept of remission provides only a vague theoretical definition that may be influenced by the psychometric limitations of available instruments [52, 53].”

    From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [52]

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Authors
Østergaard, S. D., Bech, P., & Miskowiak, K. W.
Affiliations
  • Aarhus University Hospital (DK)
  • Copenhagen University Hospital (DK)
Corresponding author
Bech, Per
ORCID
Venue
Journal of Affective Disorders
Publisher
Elsevier BV
Published
2016-01
Volume
190
Pages
842-845
ISSN
0165-0327 (ISSN-L)
DOI
10.1016/j.jad.2014.10.047
OpenAlex
W2002287069
Cited by
55
References
20
Citations by year
2026: 4 · 2025: 7 · 2024: 13 · 2023: 2 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 4 · 2018: 4 · 2017: 6 · 2016: 1 · 2015: 3
FWCI
2.45
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Affective Disorders (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders
Lundbeckfonden (R155-2014-1724, R165–2013–15320)
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
Keywords
Hamilton Depression Rating Scale, HAM-D-17, antidepressant efficacy, treatment-resistant depression, erythropoietin, augmentation therapy, sample size determination, scalability, responsiveness, Mokken analysis
MeSH terms
Adult, Antidepressive Agents, Erythropoietin, Female, Humans, Male, Psychiatric Status Rating Scales, Psychometrics, Reproducibility of Results, Outcome Assessment, Health Care, Depressive Disorder, Treatment-Resistant

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