PedophiliaPhase 4NCT01541150
Impaired Decision Making in Pedophilic Offenders
A Phase 4 study testing neuropsychological questionnaires in people with Pedophilia, run by University Hospital, Montpellier at 1 site in France.
Trial 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. 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?
- neuropsychological questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Jan 2017
- Phase
- Phase 4
- 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
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, 34295
Lacambre Mathieu, MD, 04 67 33 85 77, m-lacambre@chu-montpellier.fr
Lacambre Mathieu, MD
About this study
Official title: Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
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.
Read the detailed description
Cross-sectional study, comparing a group of 64 pedophilic offenders inmates condamned with a group of 64 volunteers non-pedophiles matched by age and level of study.
- Conditions
- Pedophilia
- Being tested
- neuropsychological questionnaires
- Keywords
- Pedophilia, Impaired Decision making, Insight, Cognitive Distorsions, Impulsiveness
- Medical subject headings
- Pedophilia, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological questionnairesBehavioural
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
| Study group | Role | What they receive |
|---|---|---|
| patient suffering pedophilia | Active comparator | This group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires Receives: Behavioral: neuropsychological questionnaires |
| control group | Placebo comparator | This group is the placebo comparator Receives: Behavioral: neuropsychological questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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...)
Measured: 36 months (at the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2015 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lacambre Mathieu, MD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541150
- Sponsor's protocol ID
- 8673
- Other IDs
- 2011-A00402-39
- Status last verified
- Feb 2012
- First submitted
- 23 Feb 2012
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
- ClinicalTrials.gov ID
- NCT01541150
- Acronym / sponsor ID
- 8673
- Conditions
- Pedophilia
- Keywords
- Pedophilia, Impaired Decision making, Insight, Cognitive Distorsions, Impulsiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 29 Feb 2012 (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.
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.
Detailed description
Cross-sectional study, comparing a group of 64 pedophilic offenders inmates condamned with a group of 64 volunteers non-pedophiles matched by age and level of study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient suffering pedophilia | Active comparator | Behavioral: neuropsychological questionnairesThis group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires |
| control group | Placebo comparator | Behavioral: neuropsychological questionnairesThis group is the placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For the controls, lack of diagnosis of disorders of sexual behavior (paraphilias) current or past (DSM IV)
- For the pedophilic offenders:
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| neuropsychological questionnairesDue to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study. | Behavioural | control group, patient suffering pedophilia |
Primary outcome
Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia
Time frame: 36 months (at the end of the study)
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...)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Pedophilia
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.
Lacambre Mathieu, MD principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing neuropsychological questionnaires in people with Pedophilia, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lacambre Mathieu, MD (04 67 33 85 77, m-lacambre@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia (time frame: 36 months (at the end of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2014.