Clinical trial NCT01743209: Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists
Official title: A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraphilia
Keywords: androgen antagonists
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 213
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients sex offenders with paraphilia and treatment with androgen antagonists

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* diagnosis of paraphilia based on DSM-IV-TR
* antecedent of sexual offence

Exclusion Criteria:

* no diagnostic of paraphilia

Primary outcomes:
measure: current deviant sexual activity assessed with the frequency of deviant sexual activity per month
timeFrame: first visit (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Florence THIBAUT, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Heloise Delavenne, MD
role: STUDY_CHAIR
affiliation: University Hospital, Rouen
name: Sandrine LAMY, MD
role: STUDY_CHAIR
References: