Impaired Decision Making in Pedophilic Offenders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014