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

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ClinicalTrials.gov Identifier: NCT02822664
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment Phase
Pedophilia Behavioral: Pedophiles patients Behavioral: Healthy subjects Device: PET/MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
Study Start Date : June 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Pedophiles patients
Adults diagnosed with pedophilia
Behavioral: Pedophiles patients
cerebral MRI and/or cerebral PET imaging

Device: PET/MRI
Healthy subjects
Healhy subjects (not diagnosed with pedophilia)
Behavioral: Healthy subjects
cerebral MRI and/or cerebral PET imaging

Device: PET/MRI



Primary Outcome Measures :
  1. BOLD contrast signal [ Time Frame: 3 months ]
    Assesment of physiological measurements by Magnetic resonance imaging (MRI)

  2. Local cerebral blood flow [ Time Frame: 3 months ]
    Assesment of physiological measurements by Positron Emission Tomography (PET)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822664


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Michel PUGEAT, Prof Hospices Civils de Lyon
Publications of Results:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02822664    
Other Study ID Numbers: 2008-535
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Brain, pedophilia, neuroimaging
Additional relevant MeSH terms:
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Pedophilia
Paraphilic Disorders
Mental Disorders