Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 7:54 PM
Study NCT ID:
NCT01124032
Status:
UNKNOWN
Last Update Posted:
2010-05-14
First Post:
2010-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-05-13', 'studyFirstSubmitDate': '2010-05-13', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOVA score', 'timeFrame': 'assessed twice, separated by 1-2 weeks.'}, {'measure': 'IGT score', 'timeFrame': 'assessed twice, separated by 1-2 weeks'}, {'measure': 'FPGT score', 'timeFrame': 'assessed twice, separated by 1-2 weeks'}, {'measure': 'SWM score', 'timeFrame': 'assessed twice, separated by 1-2- weeks'}, {'measure': 'digit span score', 'timeFrame': 'assessed twice, separated by 1-2- weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ADHD']}, 'referencesModule': {'references': [{'pmid': '20424828', 'type': 'BACKGROUND', 'citation': 'Agay N, Yechiam E, Carmel Z, Levkovitz Y. Non-specific effects of methylphenidate (Ritalin) on cognitive ability and decision-making of ADHD and healthy adults. Psychopharmacology (Berl). 2010 Jul;210(4):511-9. doi: 10.1007/s00213-010-1853-4. Epub 2010 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults in the age of 21-50\n\nExclusion Criteria:\n\n1. People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.\n2. People for whom there is a contra-indication for consuming Ritalin.\n3. Pregnant women and nursing women;'}, 'identificationModule': {'nctId': 'NCT01124032', 'briefTitle': 'A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'orgStudyIdInfo': {'id': 'SHA 01-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHD adults', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'healthy adults', 'interventionNames': ['Drug: methylphenidate']}], 'interventions': [{'name': 'methylphenidate', 'type': 'DRUG', 'description': 'a capsule containing 20 mg', 'armGroupLabels': ['ADHD adults', 'healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'country': 'Israel', 'contacts': [{'name': 'Ziv Carmel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'nirit agay, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shalvata Mental Health center', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'centralContacts': [{'name': 'Ziv Carmel, MD', 'role': 'CONTACT', 'email': 'zivca@clalit.org.il', 'phone': '97297478570'}, {'name': 'Nirit Agay, Msc', 'role': 'CONTACT', 'email': 'niritag@clalit.org.il', 'phone': '97297478644'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ziv Carmel,MD', 'oldOrganization': 'shalvata Mental health center'}}}}