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.

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.
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.
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).
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
  • 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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