Sexual offenders with paraphilia MedDRA version: 20.0 Level: PT Classification code 10033888 Term: Paraphilia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Pharmaceutical Form:
Pharmaceutical Form:
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: SSRI Group: Determining factors associated with maintaining effectiveness. Anti-androgen group: estimation of the incidence of adverse events and the determination of factors associated with the occurrence of these events, which could be different from those usually observed in the treatment of prostate cancer. ; Secondary Objective: SSRI group: incidence of adverse events and determination of associated factors Anti-androgen group: determination of factors associated with maintaining the efficacy of treatment Other Secondary Objectives: (see details in the protocol) Estimation of the relapse rate (deviant sexual behavior) Role of psychiatric comorbidity, personality disorders Treatment compliance Changes in the clinical and cognitive characteristics of sex offenders over time Role of life trajectories Research of genetic factors ; Primary end point(s): Main evaluation criterion SSRI group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-assessment) measured every 3 months; Anti-androgen group: incidence of adverse events: report of adverse events (CTC), biological parameters and other measures such as depression and suicidal intentionality as well as bone mineralization Secondary evaluation criteria SSRI Group: Incidence of Adverse Events: Report of Any Adverse Events (CTCs) Anti-androgen group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-evaluation) measured every 3 months Other evaluation criteria: See protocol ;Timepoint(s) of evaluation of this end point: 3 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary evaluation criteria SSRI Group: Incidence of Adverse Events: Report of Any Adverse Events (CTCs) Anti-androgen group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-evaluation) measured every 3 months ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed