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

Paraphilia Clinical Trial

— ESPARA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04316650
• Other study ID #: P150962J
• Secondary ID: 2017-004984-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: October 2027

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florence THIBAUT, Md, PhD
• Phone: +33 1 58 41 16 79
• Email: florence.thibaut[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Man

• At least one sex offence
• Paraphilia (DSM-5 criteria )
• Receiving pharmacological treatment ( ISRS or anti-androgen or none of them)
• Age between 18 and 65 years
• Patient 100% covered by social security

Exclusion Criteria:

• no consent
• female
• aged under 18 or over 65 years
• subject receiving simultaneous ISRS and anti-androgen treatment before enrolment
• incarcerated
• Subject under guardianship (patients under curatorship may however be included),
• no social security registration
• contraindications or allergies to treatments

Related Conditions & MeSH terms

• Paraphilia

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual desire and activity intensity scale	ISRS Group and no pharmacological treatment group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms. (Lickert's scale, scale range : 0 to 7)	Change from inclusion at 36 months
Primary	Incidence of adverse events	Anti-Androgen Group and no pharmacological treatment group : Report of any adverse event: the type, frequency, time of occurrence of adverse events	36 months
Secondary	Sexual desire intensity scale	Anti-Androgen Group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms	Every 3 months up to 36 months
Secondary	Incidence of adverse events	ISRS Group: Report of any adverse event: the type, frequency, time of occurrence of adverse events	Every 3 months up to 36 months
Secondary	Clinical factors	All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account clinical factors listed above.	Every 3 months up to 36 months
Secondary	Psychological factors	All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account psychological factors listed above.	Every 3 months up to 36 months
Secondary	Demographic factors	All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account demographic factors listed above.	Every 3 months up to 36 months
Secondary	Relapse rate	Must stay rare event (low expected number, sexual offense risk evaluated in literature around 10%when the treatment is controlled regularly, the relapses are statistically analysed if the numbers is sufficient, but it can not be a principal assessment because of their rarity).	Every 3 months up to 36 months