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

What Was Tested

This randomized controlled trial paper looks at Triptorelin.

The absence of real-life stimulants to test for actual recidivism limits possible findings.

Why It Was Studied

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.

Who Took Part

The age groups tagged for this paper are adults, men only.

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).

Changes in psychosexual characteristics using the Multiphasic Sex Inventory (scale: sexual abuse of children) 2.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter, parallel-group and pilot study.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Triptorelin.

The comparison arm used a placebo, so changes seen with Triptorelin could be set against what happens without it.

Running at several centres spread the Triptorelin study over different clinics and patient groups.

A time span of 12 months appears in the methods.

This is a pilot study, therefore exploratory data analyses will be carried out of three different target parameters: 1.

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).

What Was Measured

PubMed files the paper under topics including Androgen Antagonists, Clinical Protocols, Combined Modality Therapy, Criminals, Pedophilia, Pilot Projects and Psychotherapy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Triptorelin over 12 months.

The publication is from 2012 (The Israel journal of psychiatry and related sciences), a journal based in Israel.

More context: the Triptorelin compound page, all human trials.