Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-26 @ 3:49 PM
Study NCT ID:
NCT01541150
Status:
UNKNOWN
Last Update Posted:
2014-12-31
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impaired Decision Making in Pedophilic Offenders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010378', 'term': 'Pedophilia'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D010262', 'term': 'Paraphilic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia', 'timeFrame': '36 months (at the end of the study)', 'description': '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).\n\nThe 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...)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pedophilia', 'Impaired Decision making', 'Insight', 'Cognitive Distorsions', 'Impulsiveness'], 'conditions': ['Pedophilia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the controls, lack of diagnosis of disorders of sexual behavior (paraphilias) current or past (DSM IV)\n* For the pedophilic offenders:\n\n * Placement and conviction for rape or sexual assault of a minor under 15 years\n * Recognition of the facts\n * Existence of a current or past diagnosis of pedophilia (according to the DSM IV).\n\nExclusion Criteria:\n\n* Presence of a current major depressive episode (DSM IV - MINI)\n* History of cerebral neurological disorder or a cranial trauma with loss of consciousness current\n* IGT test already done\n* Schizophrenia or Other current psychotic disorders(according to the criteria DSM IV of MINI test).\n* taking psychoactive drug'}, 'identificationModule': {'nctId': 'NCT01541150', 'briefTitle': 'Impaired Decision Making in Pedophilic Offenders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders', 'orgStudyIdInfo': {'id': '8673'}, 'secondaryIdInfos': [{'id': '2011-A00402-39', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patient suffering pedophilia', 'description': 'This group is the active comparator because patients suffering pedophilia with neuropsychological questionnaires', 'interventionNames': ['Behavioral: neuropsychological questionnaires']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'This group is the placebo comparator', 'interventionNames': ['Behavioral: neuropsychological questionnaires']}], 'interventions': [{'name': 'neuropsychological questionnaires', 'type': 'BEHAVIORAL', 'description': 'Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.', 'armGroupLabels': ['control group', 'patient suffering pedophilia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lacambre Mathieu, MD', 'role': 'CONTACT', 'email': 'm-lacambre@chu-montpellier.fr', 'phone': '04 67 33 85 77'}, {'name': 'Lacambre Mathieu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Lacambre Mathieu, MD', 'role': 'CONTACT', 'email': 'm-lacambre@chu-montpellier.fr', 'phone': '04 67 33 85 77'}], 'overallOfficials': [{'name': 'Lacambre Mathieu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}