title: DSM-5 and clinical trials in psychiatry: challenges to come?
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.
authors: 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
authors: Florence
authors: F
authors: Butlen-Ducuing
authors: Manuel
authors: M
authors: Haas
authors: Luca
authors: L
authors: Pani
authors: Barbara
authors: B
authors: van Zwieten-Boot
authors: Karl
authors: K
authors: Broich
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000639:trends; D039721:Diagnostic and Statistical Manual of Mental Disorders; D015195:Drug Design; D006801:Humans; D007880:Legislation, Drug; D001523:Mental Disorders / Q000145:classification / Q000175:diagnosis* / Q000188:drug therapy; D012107:Research Design