PedophiliaPCNINCT02822664
Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
A study testing Pedophiles patients, Healthy subjects and PET/MRI in people with Pedophilia, run by Hospices Civils de Lyon.
Trial summary
The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pedophilia
- What is being tested?
- Pedophiles patients, Healthy subjects and PET/MRI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of pedophilia
- Male
- Age between 18 and 65
- Informed consent signed
- Male
- Age between 18 and 65
- Informed consent signed
Who cannot join
- IQ <70
- Ongoing treatment with cyprostrerone acetate or GnRH agonist or antidepressant treatment (5HT reuptake inhibitor)
- Ongoing detention
- psychiatric disorders
- IQ<70
- Sexual disorders
About this study
The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.
- Conditions
- Pedophilia
- Being tested
- Pedophiles patients, Healthy subjects, PET/MRI
- Keywords
- Brain, pedophilia, neuroimaging
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedophiles patientsBehavioural
cerebral MRI and/or cerebral PET imaging
Healthy subjectsBehavioural
cerebral MRI and/or cerebral PET imaging
PET/MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Pedophiles patients | Other | Adults diagnosed with pedophilia Receives: Behavioral: Pedophiles patients; Device: PET/MRI |
| Healthy subjects | Other | Healhy subjects (not diagnosed with pedophilia) Receives: Behavioral: Healthy subjects; Device: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD contrast signal
Assesment of physiological measurements by Magnetic resonance imaging (MRI)
Measured: 3 months
Local cerebral blood flow
Assesment of physiological measurements by Positron Emission Tomography (PET)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJun 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PUGEAT, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822664
- Sponsor's protocol ID
- 2008-535
- Acronym
- PCNI
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30612938
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
- ClinicalTrials.gov ID
- NCT02822664
- Acronym / sponsor ID
- PCNI / 2008-535
- Conditions
- Pedophilia
- Keywords
- Brain, pedophilia, neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedophiles patients | Other | Behavioral: Pedophiles patients, Device: PET/MRIAdults diagnosed with pedophilia |
| Healthy subjects | Other | Behavioral: Healthy subjects, Device: PET/MRIHealhy subjects (not diagnosed with pedophilia) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of pedophilia
- Male
- Age between 18 and 65
- Informed consent signed
- Male
Key exclusion criteria (6 listed)
- IQ <70
- Ongoing treatment with cyprostrerone acetate or GnRH agonist or antidepressant treatment (5HT reuptake inhibitor)
- Ongoing detention
- psychiatric disorders
- IQ<70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedophiles patientscerebral MRI and/or cerebral PET imaging | Behavioural | Pedophiles patients |
| Healthy subjectscerebral MRI and/or cerebral PET imaging | Behavioural | Healthy subjects |
| PET/MRI | Device | Healthy subjects, Pedophiles patients |
Primary outcome
BOLD contrast signal
Time frame: 3 months
Assesment of physiological measurements by Magnetic resonance imaging (MRI)
Local cerebral blood flow
Time frame: 3 months
Assesment of physiological measurements by Positron Emission Tomography (PET)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 30612938Fonteille 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel PUGEAT, Prof principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A study testing Pedophiles patients, Healthy subjects and PET/MRI in people with Pedophilia, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD contrast signal (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.