Socio-demographic features of participants in randomized con-trolled trials for major depression: generalizability and individu-alization.

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Rosalind ven der Lem
Purdey M. Stamsnieder
Nic J.A. van der Wee
Tineke van Veen
Frans G. Zitman


Rationale, Aims and Objectives: It is important for clinicians to know to what extent the results of randomized controlled trials (RCTs) are generalizable to their psychiatric practice, since RCTs are considered to be the most reliable source of evidence for treatment guideline development. Furthermore, it is important to know whether results from individual randomised controlled trials (RCTs) can be directly compared to each other.  Socio-demographic and socio-economic (SES) features influence treatment-outcome in major depressive disorder (MDD). Differences in (reporting of) SES features of  participants in RCTs will hamper comparison and jeopardise the external validity (generalizability) of their results. We explored the reporting of SES features in RCTs for depression.Methods: We selected 45 antidepressant efficacy trials (AETs) and 19 psychotherapy efficacy trials (PETs). We listed the reported socio-demographic and -economic features.Results: Reporting on SES-features was very diverse and often limited. Especially important SES features like educational level, socio-economic status and income were reported insufficiently. The mean age of RCT participants in MDD trials was 41 years. Participants are predominantly female (62%) and white (89%). Of the participants 61% were employed and 45% of the participants were married/cohabitating.Conclusions: Standardisation of reporting on socio-demographic and socio-economic status is needed to adequately judge the generalizability of RCTs to daily practice and to  facilitate comparisons within the body of RCTs in order to move increasingly towards more individualized and person-centered models of clinical practice.

Article Details

Regular Articles
Author Biographies

Rosalind ven der Lem, Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands

Psychiatrist, Deparment of Psychiatry, Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands.

Purdey M. Stamsnieder, Medical Center Rijssen, Rijssen, The Netherlands.

Trainee in General Practice

Nic J.A. van der Wee, Psychiatrist, Department of Psychiatry, Leiden University Medical Center and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.

Psychiatrist, Department of Psychiatry

Tineke van Veen, Epidemiologist, Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Epidemiologist, Department of Psychiatry,

Frans G. Zitman, Professor and Head of Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Professor and Head of Department of Psychiatry


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