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

Florence Butlen-Ducuing; Manuel Haas; Luca Pani; Barbara van Zwieten-Boot; Karl Broich

doi:10.1038/nrd3811

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

Nat Rev Drug Discov. 2012 Aug;11(8):583-4. doi: 10.1038/nrd3811.

Authors

Florence Butlen-Ducuing¹, Manuel Haas, Luca Pani, Barbara van Zwieten-Boot, Karl Broich

Affiliation

¹ Central Nervous System & Ophthalmology Section, Safety & Efficacy of Medicines, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK. florence.butlen@ema. europa.eu

PMID: 22850770
DOI: 10.1038/nrd3811

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.

MeSH terms

Clinical Trials as Topic / methods*
Clinical Trials as Topic / trends
Diagnostic and Statistical Manual of Mental Disorders*
Drug Design*
Humans
Legislation, Drug
Mental Disorders / classification
Mental Disorders / diagnosis*
Mental Disorders / drug therapy
Research Design