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Cited by 63Treatment of Major DepressionMental Health Treatment and AccessPsychotherapy Techniques and Applications

The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice

van der Lem, R., van der Wee, N. J. A., van Veen, T., Zitman, F. G.·2011·Psychological Medicine
DOI 10.1017/s0033291710002175
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Abstract

Background: Generalizability of antidepressant efficacy trials (AETs) to daily practice is questioned because of their very stringent patient selection. This study aims to determine eligibility for AETs of out-patients suffering from major depression in a routine out-patient setting and investigates influence of eligibility on treatment outcome. Method: Data collection ( n =1653) was performed through routine outcome monitoring by independent trained research nurses. The Mini-International Neuropsychiatric Interview Plus and the Dimensional Assessment of Personality Pathology, short Dutch version were used for diagnostic assessment and personality pathology screening. The Montgomery–Asberg Depression Rating Scale (MADRS) was used for assessment of baseline severity and treatment outcome. Eligibility was assessed by stepwise application of commonly used exclusion criteria. Influence of eligibility on treatment outcome was investigated in a subsample of the 1653 patients who had at least one follow-up assessment ( n =626). Eligible and non-eligible patients were compared on proportion of response (50% reduction) and remission on MADRS (MADRS⩽10). Results: Altogether, 17–25% of the patients were eligible for AETs. The most common reasons for exclusion would be ‘not meeting minimum baseline severity’ and ‘presence of co-morbid Axis I disorder’. Eligible and non-eligible patients did not differ in treatment outcome. Only ‘meeting the minimum baseline severity’ is associated with remission. Conclusions: The majority of ‘real life’ out-patients are not eligible for AETs. However, the influence of eligibility on treatment outcome seems to be small. This suggests that stringent patient selection by eligibility criteria is not the major reason for lack of generalizability of AETs. Exclusion of less severely depressed patients from the analyses resulted in better treatment outcome. Milder depression is highly prevalent in daily practice and more research into treatment effectiveness in milder depression is warranted.

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  • The question of whether the treatment of depression per se has a significant effect on suicidality does not have a definitive answer, largely due to low power of trials to detect rare outcomes, though there are real-world studies which suggest an association.

    “The question of whether the treatment of depression per se has a significant effect on suicidality does not have a definitive answer, largely due to low power of trials to detect rare outcomes, though there are real-world studies which suggest an association (discussed later). 558”

    From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [558]

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Authors
van der Lem, R., van der Wee, N. J. A., van Veen, T., & Zitman, F. G.
Affiliations
Leiden University Medical Center (NL)
ORCID
Zitman, F. G.
Venue
Psychological Medicine
Publisher
Cambridge University Press (CUP)
Published
2010-11-16
Volume
41
Issue
7
Pages
1353-1363
ISSN
  • 0033-2917 (ISSN-L)
  • 1469-8978
DOI
10.1017/s0033291710002175
OpenAlex
W2143892561
Cited by
63
References
50
Citations by year
2026: 2 · 2025: 2 · 2024: 2 · 2023: 3 · 2022: 3 · 2020: 1 · 2019: 4 · 2018: 4 · 2017: 2 · 2016: 7 · 2015: 7 · 2014: 7 · 2013: 6 · 2012: 10
FWCI
4.22
Type
journal article
Language
en
Open access
closed
Licence
www.cambridge.org/core/terms (unspecified)
Locations
  • Psychological Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Leiden Repository (Leiden University) (submittedVersion)
Funders
Rivierduinen
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
generalizability, major depressive disorder, inclusion and exclusion criteria, exclusion criteria, baseline depression severity, remission, treatment response, personality pathology, comorbidities, routine outcome monitoring
MeSH terms
Adult, Ambulatory Care, Antidepressive Agents, Clinical Trials as Topic, Major Depressive Disorder, Female, Humans, Male, Netherlands, Outpatients, Practice Patterns, Physicians', Psychiatric Status Rating Scales, Research Design, Treatment Outcome, Patient Selection

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