Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01553695
Status:
COMPLETED
Last Update Posted:
2014-07-29
First Post:
2012-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-28', 'studyFirstSubmitDate': '2012-01-26', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic of ADHD using DSM-IV criteria as implemented in the DIVA', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'score of rating scales (ASRS and WURS)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Touble', 'deficit', 'attention', 'hyperactivity', 'Touble deficit attention with hyperactivity'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': "ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.\n\nAs part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.\n\nThe aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Authorization to use the data signed social security affiliation\n\nExclusion Criteria:\n\n* Patient presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\\\\or psychiatric.'}, 'identificationModule': {'nctId': 'NCT01553695', 'briefTitle': 'Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France', 'orgStudyIdInfo': {'id': '11-AOI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'general population', 'interventionNames': ['Other: questionary']}, {'type': 'EXPERIMENTAL', 'label': 'ADHD Patient', 'interventionNames': ['Other: questionary']}], 'interventions': [{'name': 'questionary', 'type': 'OTHER', 'description': 'Subjects have to fill out a booklet of questionnaires', 'armGroupLabels': ['general population']}, {'name': 'questionary', 'type': 'OTHER', 'description': 'Subjects have to fill out a booklet of questionnaires', 'armGroupLabels': ['ADHD Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'Pediatric Hospital Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Herve CACI, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nice- GCS Lenval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}