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Impaired Decision Making in Pedophilic Offenders

This study is currently recruiting participants.
Verified February 2012 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01541150
First received: February 23, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pedophilia
 Behavioral: neuropsychological questionnaires
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia [ Time Frame: 36 months (at the end of the study) ] [ Designated as safety issue: No ]

    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...)



Estimated Enrollment: 128
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: patient suffering pedophilia
This group is the active comparator because patients suffering pedophilia
 Behavioral: neuropsychological questionnaires
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
Placebo Comparator: control group
This group is the placebo comparator
 Behavioral: neuropsychological questionnaires
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541150

Contacts
Contact: Lacambre Mathieu, MD 04 67 33 85 77 m-lacambre@chu-montpellier.fr

Locations
France
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Lacambre Mathieu, MD     04 67 33 85 77     m-lacambre@chu-montpellier.fr    
Principal Investigator: Lacambre Mathieu, MD            
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Lacambre Mathieu, MD CHU de Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01541150     History of Changes
Other Study ID Numbers: 8673, 2011-A00402-39
Study First Received: February 23, 2012
Last Updated: February 23, 2012
Health Authority: Afssaps: French Health Products Safety Agency

Keywords provided by University Hospital, Montpellier:
Pedophilia
Impaired Decision making
Insight
Cognitive Distorsions
Impulsiveness

Additional relevant MeSH terms:
Pedophilia
Paraphilias
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013