- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541150
Impaired Decision Making in Pedophilic Offenders
Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- CHU de Montpellier
-
Contact:
- Lacambre Mathieu, MD
- Phone Number: 04 67 33 85 77
- Email: m-lacambre@chu-montpellier.fr
-
Principal Investigator:
- Lacambre Mathieu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: patient suffering pedophilia
This group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires
|
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
|
|
Placebo Comparator: control group
This group is the placebo comparator
|
Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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...) |
36 months (at the end of the study)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lacambre Mathieu, MD, CHU de Montpellier
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8673
- 2011-A00402-39 (Other Identifier: ID-RCB)
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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