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

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Paraphilia

Treatments

Other: osteodensitometry
Other: ECG
Genetic: Blood and saliva samples
Behavioral: Evaluation Scales
Biological: blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT04316650
2017-004984-11 (EudraCT Number)
P150962J

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 3 patient groups

SSRI Group
Other group
Description:
Treated by ISRS at inclusion
Treatment:
Behavioral: Evaluation Scales
Other: osteodensitometry
Biological: blood samples
Genetic: Blood and saliva samples
Other: ECG
Anti-androgen Group
Other group
Description:
Treated by anti-androgen at inclusion
Treatment:
Behavioral: Evaluation Scales
Other: osteodensitometry
Biological: blood samples
Genetic: Blood and saliva samples
Other: ECG
No SSRIs or antiandrogen treatment at inclusion
Other group
Description:
no treatment
Treatment:
Behavioral: Evaluation Scales
Other: osteodensitometry
Biological: blood samples
Genetic: Blood and saliva samples
Other: ECG

Trial contacts and locations

1

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Central trial contact

Florence THIBAUT, Md, PhD; Audrey BECLIN

Data sourced from clinicaltrials.gov

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