Paraphilia Clinical Trial
— EPIPARAOfficial title:
A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment
The main objective of the study is to describe the french population of individuals with
paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed.
The secondary objectives are the description of social demographic profiles, the personal
and family histories,psychiatric co-morbidities, the side effects of androgen antagonists
treatment. This study, the first of its kind in France, may allow to better understand the
social demographic and clinical profile of sexual offenders with paraphilias treated with
androgen antagonists.
To be included, the subject must have committed a sexual offense and must present a
diagnosis of paraphilia with an indication of treatment with androgen antagonists.
Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder
characterized by "sexually arousing fantasies, needs or recurrent and intense sexual
behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of
oneself or partner, (3) children or other persons without their consent, occurring during a
period of at least six months "(Criterion A). This disorder is responsible for sexual
behavior which is "clinically significant disturbances in social, occupational or other
important areas of functioning" (Criterion B).
The inclusion of approximately 200 subjects is expected in this study. The inclusion period
will last for 12 months.
Data will be codified and only a few investigators will have access to these data. The
statistical analyse will use the usual descriptive parameters: mean, standard deviation,
median, interquartile range and range for quantitative variables, frequencies and cumulative
frequencies (if applicable) for qualitative variables.
Status | Completed |
Enrollment | 213 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - diagnosis of paraphilia based on DSM-IV-TR - antecedent of sexual offence Exclusion Criteria: - no diagnostic of paraphilia |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Rouen | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | current deviant sexual activity assessed with the frequency of deviant sexual activity per month | The primary outcome measure concerns the patient current deviant sexual activity. These data are reported routinely by the patient during his medical consultation and consigned in the medical record. | first visit (day 1) | No |
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