Vom Scheitern einer Studie in Maßregelvollzugskrankenhäusern: klinische Prüfung zum additiven Effekt von Triptorelin auf die Wirksamkeit von Psychotherapie = Failure of a study in forensic psychiatric hospitals

Background: A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medicati...

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Bibliographic Details
Authors: Briken, Peer 1969- (Author) ; Kasperk, Christian 1959- (Author)
Format: Electronic Article
Language:German
English
Published: 13. März 2017
In: Der Nervenarzt
Year: 2017, Volume: 88, Issue: 5, Pages: 480-485
Online Access: Volltext (Verlag)
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Keywords:
Sexualstraftäter
Ethikkommission
Pädophilie
Testosteron
Arzneimittelgesetz
Sexual offenders
Ethics committee
Pedophilia
Testosterone
Drug legislation
Description
Summary:Background: A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medication, is still lacking.AimThis article describes the process from the planning to the rejection of a clinical trial over the period from 2009 to 2015.Methods and resultsDespite the careful planning with an interdisciplinary team and giving special consideration to the complex legal situation, the Federal Institute for Drugs and Medical Devices (BfArM) rejected the proposed trial in a brief formal letter with reference to the German Drug Law (§ 40 para. 1 p. 3 nr. 4 AMG). The ethics committee of the Hamburg Medical Association considered that clinical research is basically not possible with patients detained in a forensic psychiatric hospital.DiscussionIn the opinion of the authors, the described facts illustrate how legal regulations that should protect vulnerable groups in medical research, in a specific case can lead to the fact that a therapy form relevant to the corresponding patient group cannot be scientifically investigated.
Item Description:Gesehen am 19.07.2018
Physical Description:6
ISSN:1433-0407
DOI:10.1007/s00115-017-0301-7