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Impaired Decision Making in Pedophilic Offenders

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ClinicalTrials.gov Identifier: NCT01541150
Recruitment Status : Unknown
Verified February 2012 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : February 29, 2012
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Pedophilia Behavioral: neuropsychological questionnaires Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
Study Start Date : August 2011
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Active Comparator: patient suffering pedophilia
This group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires
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.



Primary Outcome Measures :
  1. Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia [ Time Frame: 36 months (at the end of the study) ]

    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...)




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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01541150     History of Changes
Other Study ID Numbers: 8673
2011-A00402-39 ( Other Identifier: ID-RCB )
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: February 2012

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

Additional relevant MeSH terms:
Pedophilia
Paraphilic Disorders
Mental Disorders