Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia

Summary

This research concerns the evaluation of the maintenance of the efficiency and incidence of adverse effects of pharmacological treatments in sex offenders with paraphilia.

Despite the increasing use of pharmacological treatments in these indications, there are few data to indicate which sex offender populations benefit from which pharmacological treatments and which adverse events are observed, particularly with anti-androgens or antidepressant treatments that are widely used in these subjects. A recent Cochrane study showed that psychodynamic treatment is less effective in terms of sexual delinquency compared to probation alone and has not shown significant efficacy of cognitive behavioral therapy (CBT) compared to the lack of treatment, except for a study in which anti-androgen therapy was associated with CBT. Another recent study concluded that the tolerance, even of anti-androgenic drugs, was uncertain, as all studies were small and of limited duration, and new research is needed in the future. Further research demonstrating the efficacy of SSRIs in the treatment of paraphilic disorders is still needed and long-term studies are lacking. Their use for this indication is still off label.

As far as we know, this cohort should be the largest population of paraphilic sex offenders studied for the longest time to date in a field where research is insufficient. This large sample receiving routine care and followed for 3 years should allow to analyse the maintenance of the effectiveness of the pharmacological treatments received (SSRIs or anti-androgens), and their tolerance. In addition, this analysis of clinical practices should be crucial to improve the knowledge of the indications for these treatments, which could possibly be reviewed with respect to their effectiveness and tolerance, especially in the most serious cases of paraphilic sex offenders.

Conditions

• Paraphilia

Interventions

BEHAVIORAL

Evaluation Scales

* PATHOS / PEACCE : hypersexuality diagnostic scale * PDQ-4+: Personality Diagnostic Questionnaire version 4 * AUDIT * Life trajectory : THQ * Cognitive function (MoCA, Stroop) * ISDSS: and self report of sexual activity and desire * BARS: Brief Adhesion Rating Scale (treatment observance) * SF-36 scale : quality of life * BDI-II : Beck Depression Inventory * BSSI ; Beck suicidal Inventory * Cognitive functioning evaluation : Molest and Rape Scale * Empathy: EMPAT * Evaluation of Cognitive functioning: denial evaluation and Mc Kibben minimization * Baratt Impulsivity Scale * CSBI * Static 99 and Stable 2007

OTHER

osteodensitometry

Osteodensitometry

BIOLOGICAL

blood samples

* Lipid profile (total cholesterol, triglycerides, HDL cholesterol) * Liver function (ASAT, ALAT, total bilirubin, transferase gamma-glutamyl et alcalin phosphatases * Kydney function * Blood count * Biological Measurements and Measurement of Systematic Plasma Testosterone and TeBG Levels in Sex Offenders check for pathology of the Gonadotropin Axis * Biological Measurements of Plasma Prolactin level

OTHER

ECG

ECG (heart rate, search for cardiac conduction disorders or cardiac arrhythmias)

GENETIC

Blood and saliva samples

Blood and saliva samples

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Florence THIBAUT, MD, PhD · CHU Cochin, Groupe Hospitalier Paris Centre

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-30

Primary Completion

2026-12-31

Completion

2027-10-31

Countries

• France

Study Locations