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

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.

Study Overview

• Status: Withdrawn
• Conditions: Paraphilia
• Intervention / Treatment: Other: osteodensitometry; Biological: blood samples; Other: ECG; Genetic: Blood and saliva samples; Behavioral: Evaluation Scales

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hopital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SSRI Group; Treated by ISRS at inclusion	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; 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: Anti-androgen Group; Treated by anti-androgen at inclusion	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; 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: No SSRIs or antiandrogen treatment at inclusion; no treatment	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Florence THIBAUT, MD, PhD, CHU Cochin, Groupe Hospitalier Paris Centre

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacological treatment; Psychological treatment; Side effects; Paraphilia; SSRI anti-androgen; Preservation of efficiency
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: P150962J; 2017-004984-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No