Clinical trial NCT04316650: Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
Official title: Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Paraphilia
Keywords: Paraphilia
SSRI anti-androgen
Psychological treatment
Preservation of efficiency
Pharmacological treatment
Side effects
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual desire and activity intensity scale
timeFrame: Change from inclusion at 36 months
measure: Incidence of adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Sexual desire intensity scale
timeFrame: Every 3 months up to 36 months
measure: Incidence of adverse events
timeFrame: Every 3 months up to 36 months
measure: Clinical factors
timeFrame: Every 3 months up to 36 months
measure: Psychological factors
timeFrame: Every 3 months up to 36 months
measure: Demographic factors
timeFrame: Every 3 months up to 36 months
measure: Relapse rate
timeFrame: Every 3 months up to 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: CHU Cochin, Groupe Hospitalier Paris Centre
name: Florence THIBAUT, MD, PhD
role: STUDY_CHAIR
References: