Impaired Decision Making in Pedophilic Offenders

Pedophilia Clinical Trial

Official title:

Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01541150
• Other study ID #: 8673
• Secondary ID: 2011-A00402-39
• Status: Recruiting
• Phase: Phase 4
• First received: February 23, 2012
• Last updated: December 30, 2014
• Start date: August 2011
• Est. completion date: January 2017

Study information

• Verified date: February 2012
• Source: University Hospital, Montpellier
• Contact: Lacambre Mathieu, MD
• Phone: 04 67 33 85 77
• Email: m-lacambre[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Pedophilic behaviors represent a public health problem with serious consequences. The investigators hypothesize a disruption in the decision-making strategies among sex offenders pedophiles. Highlight this type of abnormality would offer a specific treatment of a possible neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid recurrences of this type of behavior.

Description:

Cross-sectional study, comparing a group of 64 pedophilic offenders inmates condamned with a group of 64 volunteers non-pedophiles matched by age and level of study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• For the controls, lack of diagnosis of disorders of sexual behavior (paraphilias) current or past (DSM IV)

• For the pedophilic offenders:

• Placement and conviction for rape or sexual assault of a minor under 15 years

• Recognition of the facts

• Existence of a current or past diagnosis of pedophilia (according to the DSM IV).

Exclusion Criteria:

• Presence of a current major depressive episode (DSM IV - MINI)

• History of cerebral neurological disorder or a cranial trauma with loss of consciousness current

• IGT test already done

• Schizophrenia or Other current psychotic disorders(according to the criteria DSM IV of MINI test).

• taking psychoactive drug

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pedophilia

Intervention

Behavioral:
• neuropsychological questionnaires
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia	Bring to light cognitive changes in the pedophilia, by comparing the neuropsychological performances of a group of persons suffering from pedophilia to a control group (no pedophile).; The neuropsychological performances between two groups are assessed by neuropsychologic questionnaires (Iowa Gambling Task, MINI 5.0.0, MADRS, Test de Rolls, N-Back, WAIS III, go-no-go...)	36 months (at the end of the study)	No