Impaired Decision Making in Pedophilic Offenders
Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
2 other identifiers
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedDecember 31, 2014
February 1, 2012
4 years
February 23, 2012
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
patient suffering pedophilia
ACTIVE COMPARATORThis group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires
control group
PLACEBO COMPARATORThis group is the placebo comparator
Interventions
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Montpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lacambre Mathieu, MD
CHU de Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
August 1, 2011
Primary Completion
August 1, 2015
Study Completion
January 1, 2017
Last Updated
December 31, 2014
Record last verified: 2012-02