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...
Authors: | ; |
---|---|
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) Volltext (Verlag) |
Journals Online & Print: | |
Check availability: | HBZ Gateway |
Keywords: |
MARC
LEADER | 00000caa a2200000 4500 | ||
---|---|---|---|
001 | 1577768043 | ||
003 | DE-627 | ||
005 | 20230426230713.0 | ||
007 | cr uuu---uuuuu | ||
008 | 180719s2017 xx |||||o 00| ||ger c | ||
024 | 7 | |a 10.1007/s00115-017-0301-7 |2 doi | |
035 | |a (DE-627)1577768043 | ||
035 | |a (DE-576)507768043 | ||
035 | |a (DE-599)BSZ507768043 | ||
035 | |a (OCoLC)1341013932 | ||
040 | |a DE-627 |b ger |c DE-627 |e rda | ||
041 | |a ger |a eng | ||
100 | 1 | |a Briken, Peer |d 1969- |e VerfasserIn |0 (DE-588)122406338 |0 (DE-627)081924941 |0 (DE-576)293256306 |4 aut | |
109 | |a Briken, Peer 1969- |a Briken, P. 1969- | ||
245 | 1 | 0 | |a Vom Scheitern einer Studie in Maßregelvollzugskrankenhäusern |b klinische Prüfung zum additiven Effekt von Triptorelin auf die Wirksamkeit von Psychotherapie = Failure of a study in forensic psychiatric hospitals |c Peer Briken, Jürgen L. Müller, Wolfgang Berner, Rolf-Hasso Bödeker, Jochen Vollmann, Christian Kasperk, Matthias Koller |
246 | 3 | 1 | |a Failure of a study in forensic psychiatric hospitals |
264 | 1 | |c 13. März 2017 | |
300 | |a 6 | ||
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Gesehen am 19.07.2018 | ||
520 | |a 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. | ||
546 | |a Zusammenfassung in deutscher und englischer Sprache, Artikel in deutscher Sprache | ||
700 | 1 | |a Kasperk, Christian |d 1959- |e VerfasserIn |0 (DE-588)1032499796 |0 (DE-627)738500615 |0 (DE-576)324873050 |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Der Nervenarzt |d Berlin : Springer, 1996 |g 88(2017), 5, Seite 480-485 |h Online-Ressource |w (DE-627)25463835X |w (DE-600)1462945-8 |w (DE-576)074531468 |x 1433-0407 |7 nnns |
773 | 1 | 8 | |g volume:88 |g year:2017 |g number:5 |g pages:480-485 |g extent:6 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00115-017-0301-7 |x Verlag |x Resolving-System |3 Volltext |
856 | 4 | 0 | |u https://link.springer.com/article/10.1007/s00115-017-0301-7 |x Verlag |3 Volltext |
936 | u | w | |d 88 |j 2017 |e 5 |h 480-485 |g 6 |
951 | |a AR | ||
ELC | |a 1 | ||
LOK | |0 000 xxxxxcx a22 zn 4500 | ||
LOK | |0 001 3028983583 | ||
LOK | |0 003 DE-627 | ||
LOK | |0 004 1577768043 | ||
LOK | |0 005 20181017102609 | ||
LOK | |0 008 181017||||||||||||||||ger||||||| | ||
LOK | |0 040 |a DE-21-110 |c DE-627 |d DE-21-110 | ||
LOK | |0 689 |a s |a Sexualstraftäter | ||
LOK | |0 689 |a s |a Ethikkommission | ||
LOK | |0 689 |a s |a Pädophilie | ||
LOK | |0 689 |a s |a Testosteron | ||
LOK | |0 689 |a s |a Arzneimittelgesetz | ||
LOK | |0 689 |a s |a Sexual offenders | ||
LOK | |0 689 |a s |a Ethics committee | ||
LOK | |0 689 |a s |a Pedophilia | ||
LOK | |0 689 |a s |a Testosterone | ||
LOK | |0 689 |a s |a Drug legislation | ||
LOK | |0 852 |a DE-21-110 | ||
LOK | |0 852 1 |9 00 | ||
LOK | |0 935 |a krub | ||
ORI | |a SA-MARC-krimdoka001.raw |