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Double-blind, controlled, clinical trial planned in germany to investigate the efficacy of psychotherapy combined with triptorelin in adult male patients with severe pedophilic disorders: presentation of the study protocol.

AbstractBACKGROUND:
The treatment of paraphilias, especially of pedophilia, centers upon cognitive-behavioral psychotherapy and pharmacologic interventions. Two open, uncontrolled clinical studies using the synthetic LHRH-agonist triptorelin suggested that, combined with psychotherapy, antiandrogen treatment reduced deviant sexual fantasies, urges, and behaviors in paraphilic patients. There is a need for further research using controlled, randomized trials to examine the effectiveness of sexual offender treatment including psychotherapeutic and pharmacologic interventions.
OBJECTIVE:
The aim of this pilot study is to evaluate the efficacy and tolerability of cognitive-behavioral psychotherapy together with intramuscular (IM) 3-monthly injections of triptorelin in adult men with severe pedophilia.
STUDY DESIGN AND METHODS:
In this multicenter, forensic psychiatric hospital-based, double-blind, controlled, parallel group phase IV trial conducted in Germany, convicted male sexual offenders aged ≥ 18 years with pedophilia, as defined by DSM-IV-TR criteria, will be randomized to receive study-specific psychotherapy together either with triptorelin or placebo for 12 months (total of 4 injections). This is a pilot study, therefore exploratory data analyses will be carried out of three different target parameters: 1. Changes in psychosexual characteristics using the Multiphasic Sex Inventory (scale: sexual abuse of children) 2. Changes in the risk of violent sexual behavior using the Sexual Violence Risk-20 total score 3. Changes in serum testosterone concentration Treatment effects will be assessed by comparing baseline values with those at the final examination (month 12).
LIMITATIONS:
The absence of real-life stimulants to test for actual recidivism limits possible findings. The study will be conducted in agreement with the European GCP-guideline, all relevant legal requirements, and the legal framework for voluntary treatment of convicted sexual offenders in Germany.
AuthorsPeer Briken, Wolfgang Berner,
JournalThe Israel journal of psychiatry and related sciences (Isr J Psychiatry Relat Sci) Vol. 49 Issue 4 Pg. 306-13 ( 2012) ISSN: 0333-7308 [Print] Israel
PMID23585468 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Androgen Antagonists
  • Triptorelin Pamoate
Topics
  • Adult
  • Androgen Antagonists (administration & dosage, pharmacology)
  • Clinical Protocols
  • Combined Modality Therapy
  • Criminals
  • Double-Blind Method
  • Humans
  • Male
  • Pedophilia (drug therapy, therapy)
  • Pilot Projects
  • Psychotherapy (methods)
  • Sex Offenses (prevention & control)
  • Treatment Outcome
  • Triptorelin Pamoate (administration & dosage, pharmacology)

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