Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2026-01-06 @ 10:00 AM
Study NCT ID:
NCT00223561
Status:
COMPLETED
Last Update Posted:
2006-03-01
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2006-02-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]'}], 'secondaryOutcomes': [{'measure': 'Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.'}, {'measure': 'Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]'}, {'measure': 'Continuous Performance test: RT, %errors [single dose effects]'}]}, 'conditionsModule': {'keywords': ['adult'], 'conditions': ['ADHD']}, 'referencesModule': {'references': [{'pmid': '20645078', 'type': 'DERIVED', 'citation': 'Verster JC, Bekker EM, Kooij JJ, Buitelaar JK, Verbaten MN, Volkerts ER, Olivier B. Methylphenidate significantly improves declarative memory functioning of adults with ADHD. Psychopharmacology (Berl). 2010 Oct;212(2):277-81. doi: 10.1007/s00213-010-1952-2. Epub 2010 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.', 'detailedDescription': 'This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate.\n\nOn-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult ADHD patient over 21 years old\n* valid driver's license for at least 3 years\n* treated with methylphenidate\n* written informed consent\n\nExclusion Criteria:\n\n* use of illicit drugs\n* use of drugs or having medical conditions known to affect driving ability"}, 'identificationModule': {'nctId': 'NCT00223561', 'briefTitle': 'Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Utrecht Institute for Pharmaceutical Sciences'}, 'officialTitle': 'A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '02/021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'methylphenidate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3508 TB', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht Institute for Pharmaceutical Sciences', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Joris Verster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrecht Institute for Pharmaceutical Sciences'}, {'name': 'Edmund Volkerts, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Utrecht Institute for Pharmaceutical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utrecht Institute for Pharmaceutical Sciences', 'class': 'OTHER'}}}}