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Updated: May 20, 2026

The Use of Pharmacological-challenge fMRI in Pre-clinical Research: Application to the 5-HT System
Published on: April 25, 2012
DSM-5 and clinical trials in psychiatry: challenges to come?
Florence Butlen-Ducuing1, Manuel Haas, Luca Pani
1Central 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
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.
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