NCT04316650

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research uses a "naturalistic" follow-up method (over 3 years). The main objectives focuses on two main issues that are important in clinical practice: (1) the tolerance of anti-androgenic treatments traditionally used for many years in young sexual offenders with severe paraphilias (2) the maintenance of the efficiency of SSRIs not yet approved for this indication (despite their current use in the treatment of minor paraphilic disorders). The paraphilic sex offender population are divided into three groups: those receiving SSRIs, those receiving anti-androgens (either GnRH agonists or CPA) and those receiving no pharmacological treatment.

Conditions

• Paraphilia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-12-01
• Completion: 2027-10-01
• First posted: 2020-03-20
• Last updated: 2026-02-13

Locations

1 site across 1 country: France