Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
- Conditions
- Paraphilia
- Interventions
- Behavioral: Evaluation ScalesOther: osteodensitometryBiological: blood samplesOther: ECGGenetic: Blood and saliva samples
- Registration Number
- NCT04316650
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 250
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSRI Group ECG Treated by ISRS at inclusion SSRI Group osteodensitometry Treated by ISRS at inclusion SSRI Group blood samples Treated by ISRS at inclusion SSRI Group Evaluation Scales Treated by ISRS at inclusion SSRI Group Blood and saliva samples Treated by ISRS at inclusion Anti-androgen Group blood samples Treated by anti-androgen at inclusion Anti-androgen Group ECG Treated by anti-androgen at inclusion No SSRIs or antiandrogen treatment at inclusion Evaluation Scales no treatment No SSRIs or antiandrogen treatment at inclusion blood samples no treatment Anti-androgen Group Evaluation Scales Treated by anti-androgen at inclusion Anti-androgen Group Blood and saliva samples Treated by anti-androgen at inclusion No SSRIs or antiandrogen treatment at inclusion ECG no treatment Anti-androgen Group osteodensitometry Treated by anti-androgen at inclusion No SSRIs or antiandrogen treatment at inclusion osteodensitometry no treatment No SSRIs or antiandrogen treatment at inclusion Blood and saliva samples no treatment
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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.
Trial Locations
- Locations (1)
Hôpital Cochin
🇫🇷Paris, France