NCT02822664

Brief Summary

The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

May 28, 2019

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

June 30, 2016

Last Update Submit

May 23, 2019

Conditions

Pedophilia

Keywords

Brain, pedophilia, neuroimaging

Outcome Measures

Primary Outcomes (2)

  • BOLD contrast signal

    Assesment of physiological measurements by Magnetic resonance imaging (MRI)

    3 months

  • Local cerebral blood flow

    Assesment of physiological measurements by Positron Emission Tomography (PET)

    3 months

Study Arms (2)

Pedophiles patients

OTHER

Adults diagnosed with pedophilia

Behavioral: Pedophiles patientsDevice: PET/MRI

Healthy subjects

OTHER

Healhy subjects (not diagnosed with pedophilia)

Behavioral: Healthy subjectsDevice: PET/MRI

Interventions

Pedophiles patientsBEHAVIORAL

cerebral MRI and/or cerebral PET imaging

Pedophiles patients
Healthy subjectsBEHAVIORAL

cerebral MRI and/or cerebral PET imaging

Healthy subjects
PET/MRIDEVICE
Healthy subjectsPedophiles patients

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of pedophilia
  • Male
  • Age between 18 and 65
  • Informed consent signed
  • Male
  • Age between 18 and 65
  • Informed consent signed

You may not qualify if:

  • IQ \<70
  • Ongoing treatment with cyprostrerone acetate or GnRH agonist or antidepressant treatment (5HT reuptake inhibitor)
  • Ongoing detention
  • psychiatric disorders
  • IQ\<70
  • Sexual disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fonteille V, Redoute J, Lamothe P, Straub D, Lavenne F, Le Bars D, Raverot V, Moulier V, Marchand JJ, Vittoz A, Leriche C, Pugeat M, Stoleru S. Brain processing of pictures of children in men with pedophilic disorder: A positron emission tomography study. Neuroimage Clin. 2019;21:101647. doi: 10.1016/j.nicl.2018.101647. Epub 2018 Dec 24.

    PMID: 30612938RESULT

MeSH Terms

Conditions

Pedophilia

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental Disorders

Study Officials

  • Michel PUGEAT, Prof

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

June 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 28, 2019

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share