Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques (PCNI)

May 23, 2019 updated by: Hospices Civils de Lyon
The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria (for patients):

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

Inclusion Criteria (for healthy patients):

  • Male
  • Age between 18 and 65
  • Informed consent signed

Exclusion Criteria (for patients):

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

Exclusion Criteria (for healthy patients):

  • psychiatric disorders
  • IQ<70
  • Sexual disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pedophiles patients
Adults diagnosed with pedophilia
Behavioral: Pedophiles patients
cerebral MRI and/or cerebral PET imaging
Device: PET/MRI
Other: Healthy subjects
Healhy subjects (not diagnosed with pedophilia)
Device: PET/MRI
Behavioral: Healthy subjects
cerebral MRI and/or cerebral PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD contrast signal
Time Frame: 3 months
Assesment of physiological measurements by Magnetic resonance imaging (MRI)
3 months
Local cerebral blood flow
Time Frame: 3 months
Assesment of physiological measurements by Positron Emission Tomography (PET)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Michel PUGEAT, Prof, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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