Study of maintenance of the efficacy and adverse effects of pharmacological treatments in sex offenders with paraphilia

Phase 1

• Conditions: Sexual offenders with paraphilia; MedDRA version: 20.0 Level: PT Classification code 10033888 Term: Paraphilia System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-004984-11-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.) Sexual offenders (sexual offense or assault including exhibitionism, rape, sexual touching, incest, possession of video material of a child pornography nature) (severity level 2 to 6 as recommended by the WFSBP)

2.) Men with paraphilic disorders (DSM-5 criteria described in Chapter 4)

3.) Receiving pharmacological treatments, either SSRI or antiandrogenic treatments. Levels 2-6 of severity of paraphilic disorders (DSM-5 criteria) will be included (see Chapter 2 for definition of 6 levels, WFSBP recommendations for pharmacological treatment of paraphilias). According to current recommendations, patients with level 2 and 3 severity should receive SSRIs and they above level 3 severity should receive antiandrogens, but the treatment decision is made by the psychiatrist in charge of the patient before the inclusion in this study (design of the naturalistic study).

4.) Aged 18 to 65 years

5.) Patients 100% covered by their medical cover for the treatment of their paraphilia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.) Subjects under the age of 18 or over 65
2.) Subject in prison (whatever the reason)
3.) Female subjects
4.) Subjects under guardianship
5.) Subjects who have committed a sexual offense and who do not meet the criteria for a paraphilic disorder (eg rape of a spouse or friend under the influence of alcohol)
6.) No registration with the social security system
7.) Refusal of consent
8.) Subjects concomitantly receiving SSRIs and antiandrogens at baseline
9.) Contraindications or allergies to the treatments used

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified