Status:
NOT_YET_RECRUITING
Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Paraphilia
Eligibility:
MALE
18-65 years
Phase:
NA
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 ...
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04316650
Start Date
June 1 2023
End Date
October 1 2027
Last Update
February 13 2023
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014