Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01675804
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2012-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2012-07-29', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persian software for the continuous performance test [CPT]', 'timeFrame': '5 months', 'description': 'The Persian software of CPT is a visual CPT test.'}, {'measure': 'Persian software for the Tower of London Test [TOL]', 'timeFrame': '5 months', 'description': 'Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.'}, {'measure': 'Forward/Reversed digit span tasks from the WISC-R testing battery.', 'timeFrame': '5 months', 'description': 'Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory.'}, {'measure': "Raven's colored progressive matrices.", 'timeFrame': '5 months', 'description': "Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning."}, {'measure': 'Span board task from the Lumosity.com online software (Lumosity.com, 2012)', 'timeFrame': '5 months'}, {'measure': 'SNAP-IV scales', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).', 'detailedDescription': 'The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADHD diagnosis\n* age between 7 and 12\n* IQ \\> 85\n\nExclusion Criteria:\n\n* sever co-morbid disorder\n* seizure\n* IQ \\< 85\n* disability\n* sever medical condition'}, 'identificationModule': {'nctId': 'NCT01675804', 'briefTitle': 'Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Allameh Tabatabai University'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '83-6516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computerized cognitive rehabilitation', 'description': '-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.', 'interventionNames': ['Other: Computerized cognitive rehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo CACR [PCACR]', 'description': '-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.', 'interventionNames': ['Other: Placebo CACR [PCACR]']}, {'type': 'EXPERIMENTAL', 'label': 'Ritalin', 'description': '-2 to 3 doses of 10 mg Ritalin tablets per day during two months.', 'interventionNames': ['Drug: Ritalin']}], 'interventions': [{'name': 'Computerized cognitive rehabilitation', 'type': 'OTHER', 'description': '\\- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.', 'armGroupLabels': ['Computerized cognitive rehabilitation']}, {'name': 'Ritalin', 'type': 'DRUG', 'otherNames': ['Immediate release methylphenidate'], 'description': '-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.', 'armGroupLabels': ['Ritalin']}, {'name': 'Placebo CACR [PCACR]', 'type': 'OTHER', 'description': 'PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.', 'armGroupLabels': ['Placebo CACR [PCACR]']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Counseling and guidence Center of the Department of education of region 9 of Tehran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Saeed Azami, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran'}, {'name': 'Alireza Moghadas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.'}, {'name': 'Faramarz Sohrabi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.'}, {'name': 'Morteza Nazifi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of psychology, University of Bojnord, Bojnord, Iran.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allameh Tabatabai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}