Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists

NCT01743209 | Completed

• 1 other identifier: 2012/057/HP
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraphilia

Keywords

androgen antagonists

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients sex offenders with paraphilia and treatment with androgen antagonists

You may qualify if:

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

You may not qualify if:

• no diagnostic of paraphilia

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital of Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Paraphilic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Florence THIBAUT, MD/PhD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Heloise Delavenne, MD

  University Hospital, Rouen

  STUDY CHAIR

• Sandrine LAMY, MD

  University Hospital, Rouen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

FR (1)