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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04316650

Collaborator

(none)

250

Enrollment

Location

Arms

58.1

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Paraphilia	Behavioral: Evaluation Scales Other: osteodensitometry Biological: blood samples Other: ECG Genetic: Blood and saliva samples	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: SSRI Group Treated by ISRS at inclusion	Behavioral: Evaluation Scales PATHOS / PEACCE : hypersexuality diagnostic scale MINI : Mini-International Neuropsychiatric Interview (comorbid psychiatric disorder) 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
Other: Anti-androgen Group Treated by anti-androgen at inclusion	Behavioral: Evaluation Scales PATHOS / PEACCE : hypersexuality diagnostic scale MINI : Mini-International Neuropsychiatric Interview (comorbid psychiatric disorder) 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
Other: No SSRIs or antiandrogen treatment at inclusion no treatment	Behavioral: Evaluation Scales PATHOS / PEACCE : hypersexuality diagnostic scale MINI : Mini-International Neuropsychiatric Interview (comorbid psychiatric disorder) 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

Arm

Intervention/Treatment

Other: SSRI Group

Treated by ISRS at inclusion

Behavioral: Evaluation Scales

PATHOS / PEACCE : hypersexuality diagnostic scale MINI : Mini-International Neuropsychiatric Interview (comorbid psychiatric disorder) 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

Other: Anti-androgen Group

Treated by anti-androgen at inclusion

Behavioral: Evaluation Scales

Other: osteodensitometry

Osteodensitometry

Biological: blood samples

Other: ECG

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

Genetic: Blood and saliva samples

Blood and saliva samples

Other: No SSRIs or antiandrogen treatment at inclusion

no treatment

Behavioral: Evaluation Scales

Other: osteodensitometry

Osteodensitometry

Biological: blood samples

Other: ECG

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

Genetic: Blood and saliva samples

Blood and saliva samples

Outcome Measures

Primary Outcome Measures

Sexual desire and activity intensity scale [Change from inclusion at 36 months]
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)
Incidence of adverse events [36 months]
Anti-Androgen Group and no pharmacological treatment group : Report of any adverse event: the type, frequency, time of occurrence of adverse events

Secondary Outcome Measures

Sexual desire intensity scale [Every 3 months up to 36 months]
Anti-Androgen Group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms
Incidence of adverse events [Every 3 months up to 36 months]
ISRS Group: Report of any adverse event: the type, frequency, time of occurrence of adverse events
Clinical factors [Every 3 months up to 36 months]
All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account clinical factors listed above.
Psychological factors [Every 3 months up to 36 months]
All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account psychological factors listed above.
Demographic factors [Every 3 months up to 36 months]
All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account demographic factors listed above.
Relapse rate [Every 3 months up to 36 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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