Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 8:29 PM
Study NCT ID:
NCT04316650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-13
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010262', 'term': 'Paraphilic Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2019-09-02', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual desire and activity intensity scale', 'timeFrame': 'Change from inclusion at 36 months', 'description': "ISRS Group and no pharmacological treatment group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms. (Lickert's scale, scale range : 0 to 7)"}, {'measure': 'Incidence of adverse events', 'timeFrame': '36 months', 'description': 'Anti-Androgen Group and no pharmacological treatment group : Report of any adverse event: the type, frequency, time of occurrence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Sexual desire intensity scale', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'Anti-Androgen Group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'ISRS Group: Report of any adverse event: the type, frequency, time of occurrence of adverse events'}, {'measure': 'Clinical factors', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account clinical factors listed above.'}, {'measure': 'Psychological factors', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account psychological factors listed above.'}, {'measure': 'Demographic factors', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account demographic factors listed above.'}, {'measure': 'Relapse rate', 'timeFrame': 'Every 3 months up to 36 months', 'description': 'Must stay rare event (low expected number, sexual offense risk evaluated in literature around 10%when the treatment is controlled regularly, the relapses are statistically analysed if the numbers is sufficient, but it can not be a principal assessment because of their rarity).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paraphilia', 'SSRI anti-androgen', 'Psychological treatment', 'Preservation of efficiency', 'Pharmacological treatment', 'Side effects'], 'conditions': ['Paraphilia']}, 'descriptionModule': {'briefSummary': 'This research concerns the evaluation of the maintenance of the efficiency and incidence of adverse effects of pharmacological treatments in sex offenders with paraphilia.\n\nDespite the increasing use of pharmacological treatments in these indications, there are few data to indicate which sex offender populations benefit from which pharmacological treatments and which adverse events are observed, particularly with anti-androgens or antidepressant treatments that are widely used in these subjects. A recent Cochrane study showed that psychodynamic treatment is less effective in terms of sexual delinquency compared to probation alone and has not shown significant efficacy of cognitive behavioral therapy (CBT) compared to the lack of treatment, except for a study in which anti-androgen therapy was associated with CBT. Another recent study concluded that the tolerance, even of anti-androgenic drugs, was uncertain, as all studies were small and of limited duration, and new research is needed in the future. Further research demonstrating the efficacy of SSRIs in the treatment of paraphilic disorders is still needed and long-term studies are lacking. Their use for this indication is still off label.\n\nAs far as we know, this cohort should be the largest population of paraphilic sex offenders studied for the longest time to date in a field where research is insufficient. This large sample receiving routine care and followed for 3 years should allow to analyse the maintenance of the effectiveness of the pharmacological treatments received (SSRIs or anti-androgens), and their tolerance. In addition, this analysis of clinical practices should be crucial to improve the knowledge of the indications for these treatments, which could possibly be reviewed with respect to their effectiveness and tolerance, especially in the most serious cases of paraphilic sex offenders.', 'detailedDescription': 'This research uses a "naturalistic" follow-up method (over 3 years). The main objectives focuses on two main issues that are important in clinical practice: (1) the tolerance of anti-androgenic treatments traditionally used for many years in young sexual offenders with severe paraphilias (2) the maintenance of the efficiency of SSRIs not yet approved for this indication (despite their current use in the treatment of minor paraphilic disorders).\n\nThe paraphilic sex offender population are divided into three groups: those receiving SSRIs, those receiving anti-androgens (either GnRH agonists or CPA) and those receiving no pharmacological treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMan\n\n* At least one sex offence\n* Paraphilia (DSM-5 criteria )\n* Receiving pharmacological treatment ( ISRS or anti-androgen or none of them)\n* Age between 18 and 65 years\n* Patient 100% covered by social security\n\nExclusion Criteria:\n\n* no consent\n* female\n* aged under 18 or over 65 years\n* subject receiving simultaneous ISRS and anti-androgen treatment before enrolment\n* incarcerated\n* Subject under guardianship (patients under curatorship may however be included),\n* no social security registration\n* contraindications or allergies to treatments'}, 'identificationModule': {'nctId': 'NCT04316650', 'acronym': 'ESPARA', 'briefTitle': 'Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia', 'orgStudyIdInfo': {'id': 'P150962J'}, 'secondaryIdInfos': [{'id': '2017-004984-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SSRI Group', 'description': 'Treated by ISRS at inclusion', 'interventionNames': ['Behavioral: Evaluation Scales', 'Other: osteodensitometry', 'Biological: blood samples', 'Other: ECG', 'Genetic: Blood and saliva samples']}, {'type': 'OTHER', 'label': 'Anti-androgen Group', 'description': 'Treated by anti-androgen at inclusion', 'interventionNames': ['Behavioral: Evaluation Scales', 'Other: osteodensitometry', 'Biological: blood samples', 'Other: ECG', 'Genetic: Blood and saliva samples']}, {'type': 'OTHER', 'label': 'No SSRIs or antiandrogen treatment at inclusion', 'description': 'no treatment', 'interventionNames': ['Behavioral: Evaluation Scales', 'Other: osteodensitometry', 'Biological: blood samples', 'Other: ECG', 'Genetic: Blood and saliva samples']}], 'interventions': [{'name': 'Evaluation Scales', 'type': 'BEHAVIORAL', 'description': '* PATHOS / PEACCE : hypersexuality diagnostic scale\n* PDQ-4+: Personality Diagnostic Questionnaire version 4\n* AUDIT\n* Life trajectory : THQ\n* Cognitive function (MoCA, Stroop)\n* ISDSS: and self report of sexual activity and desire\n* BARS: Brief Adhesion Rating Scale (treatment observance)\n* SF-36 scale : quality of life\n* BDI-II : Beck Depression Inventory\n* BSSI ; Beck suicidal Inventory\n* Cognitive functioning evaluation : Molest and Rape Scale\n* Empathy: EMPAT\n* Evaluation of Cognitive functioning: denial evaluation and Mc Kibben minimization\n* Baratt Impulsivity Scale\n* CSBI\n* Static 99 and Stable 2007', 'armGroupLabels': ['Anti-androgen Group', 'No SSRIs or antiandrogen treatment at inclusion', 'SSRI Group']}, {'name': 'osteodensitometry', 'type': 'OTHER', 'description': 'Osteodensitometry', 'armGroupLabels': ['Anti-androgen Group', 'No SSRIs or antiandrogen treatment at inclusion', 'SSRI Group']}, {'name': 'blood samples', 'type': 'BIOLOGICAL', 'description': '* Lipid profile (total cholesterol, triglycerides, HDL cholesterol)\n* Liver function (ASAT, ALAT, total bilirubin, transferase gamma-glutamyl et alcalin phosphatases\n* Kydney function\n* Blood count\n* Biological Measurements and Measurement of Systematic Plasma Testosterone and TeBG Levels in Sex Offenders check for pathology of the Gonadotropin Axis\n* Biological Measurements of Plasma Prolactin level', 'armGroupLabels': ['Anti-androgen Group', 'No SSRIs or antiandrogen treatment at inclusion', 'SSRI Group']}, {'name': 'ECG', 'type': 'OTHER', 'description': 'ECG (heart rate, search for cardiac conduction disorders or cardiac arrhythmias)', 'armGroupLabels': ['Anti-androgen Group', 'No SSRIs or antiandrogen treatment at inclusion', 'SSRI Group']}, {'name': 'Blood and saliva samples', 'type': 'GENETIC', 'description': 'Blood and saliva samples', 'armGroupLabels': ['Anti-androgen Group', 'No SSRIs or antiandrogen treatment at inclusion', 'SSRI Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Florence THIBAUT, MD, PhD', 'role': 'CONTACT', 'email': 'florence.thibaut@aphp.fr', 'phone': '+33 1 58 41 16 79'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Florence THIBAUT, Md, PhD', 'role': 'CONTACT', 'email': 'florence.thibaut@aphp.fr', 'phone': '+33 1 58 41 16 79'}, {'name': 'Audrey BECLIN', 'role': 'CONTACT', 'email': 'audrey.clabaux@aphp.fr', 'phone': '+33 1 58 41 33 82'}], 'overallOfficials': [{'name': 'Florence THIBAUT, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Cochin, Groupe Hospitalier Paris Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}