NCT01541150

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 31, 2014

Status Verified

February 1, 2012

Enrollment Period

4 years

First QC Date

February 23, 2012

Last Update Submit

December 30, 2014

Conditions

Keywords

PedophiliaImpaired Decision makingInsightCognitive DistorsionsImpulsiveness

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 COMPARATOR

This group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires

Behavioral: neuropsychological questionnaires

control group

PLACEBO COMPARATOR

This group is the placebo comparator

Behavioral: neuropsychological questionnaires

Interventions

Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.

control grouppatient suffering pedophilia

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

PedophiliaImpulsive Behavior

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental DisordersBehavior

Study Officials

  • Lacambre Mathieu, MD

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

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

Locations