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Impaired Decision Making in Pedophilic Offenders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Montpellier Identifier:
First received: February 23, 2012
Last updated: December 30, 2014
Last verified: February 2012
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
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) ]

    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: January 2017
Estimated Primary Completion Date: August 2015 (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 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.

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01541150

CHU de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Lacambre Mathieu, MD CHU de Montpellier
  More Information

Responsible Party: University Hospital, Montpellier Identifier: NCT01541150     History of Changes
Other Study ID Numbers: 8673  2011-A00402-39 
Study First Received: February 23, 2012
Last Updated: December 30, 2014

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

Additional relevant MeSH terms:
Paraphilic Disorders
Mental Disorders processed this record on February 20, 2017