Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

DSM-5 and clinical trials in psychiatry: challenges to come?

Nature Reviews Drug Discovery volume 11, pages 583–584 (2012)Cite this article

Subjects

Abstract

The publication of the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in 2013 raises important questions for clinical trials and associated regulatory decisions on new drugs for psychiatric disorders.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Regier, D. A. Dimensional approaches to psychiatric classification: refining the research agenda for DSM-V: an introduction. Int. J. Meth. Psychiatr. Res. 16, S1–S5 (2007).

    Article  Google Scholar 

  2. Kraemer, H. C., Kupfer, D. J., Clarke, D. E., Narrow, W. E. & Regier, D. A. DSM-5: how reliable is reliable enough? Am. J. Psychiatry 169, 13–15 (2012).

    Article  Google Scholar 

  3. First, M. B. DSM-5 proposals for mood disorders: a cost–benefit analysis. Curr. Opin. Psychiatry 24, 1–9 (2011).

    Article  Google Scholar 

  4. Wakefield, J. C. DSM-5: proposed changes to depressive disorders. Curr. Med. Res. Opin. 28, 335–343 (2012).

    Article  Google Scholar 

  5. Insel, T. R. & Wang, P. S. Rethinking mental illness. JAMA 303, 1970–1971 (2010).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies or the committees or working parties of the regulatory agencies the authors work for.

Author information

Authors and Affiliations

  1. Florence Butlen-Ducuing and Manuel Haas are at the Central Nervous System & Ophthalmology Section, Safety & Efficacy of Medicines, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.,

    Florence Butlen-Ducuing & Manuel Haas

  2. Luca Pani is at the Agenzia Italiana del Farmaco (AIFA), Via del Tritone, 181, 00187, Rome, Italy.,

    Luca Pani

  3. Barbara van Zwieten-Boot is at the College ter Beoordeling van Geneesmiddelen Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, Netherlands.,

    Barbara van Zwieten-Boot

  4. Karl Broich is at the Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175 Bonn, Germany.,

    Karl Broich

Authors
  1. Florence Butlen-Ducuing
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Manuel Haas
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Luca Pani
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Barbara van Zwieten-Boot
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Karl Broich
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Florence Butlen-Ducuing.

Ethics declarations

Competing interests

All authors work for drug regulatory agencies. The authors have declared that no other competing interests exist, and no specific funding was received for writing this article.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Butlen-Ducuing, F., Haas, M., Pani, L. et al. DSM-5 and clinical trials in psychiatry: challenges to come?. Nat Rev Drug Discov 11, 583–584 (2012). https://doi.org/10.1038/nrd3811

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd3811

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research