Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-04 @ 7:40 PM
Study NCT ID:
NCT01798459
Status:
UNKNOWN
Last Update Posted:
2015-03-23
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Methylphenidate Versus Placebo on State Anxiety in Children 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'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State anxiety', 'timeFrame': '1 year', 'description': "State anxiety will be measured by the Spielberger's state anxiety inventory"}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '1 year', 'description': 'Cognitive function will be measured by the cambridge neuropsychological test automated battery'}, {'measure': "Patient's perspective", 'timeFrame': '1 year', 'description': "Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder', 'Methylphenidate', 'Placebo', 'State anxiety'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '41342306', 'type': 'DERIVED', 'citation': 'Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12:CD009885. doi: 10.1002/14651858.CD009885.pub4.'}, {'pmid': '36971690', 'type': 'DERIVED', 'citation': 'Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.'}, {'pmid': '31156406', 'type': 'DERIVED', 'citation': 'Kritchman M, Koubi M, Mimouni Bloch A, Bloch Y. Effect of Methylphenidate on State Anxiety in Children With ADHD-A Single Dose, Placebo Controlled, Crossover Study. Front Behav Neurosci. 2019 May 15;13:106. doi: 10.3389/fnbeh.2019.00106. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.\n\nPatient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.\n\nStructure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attention deficit and hyperactivity disorder\n* Children aged 8-18 years\n\nExclusion Criteria:\n\n* Pervasive developmental disorder\n* Schizophrenia\n* Bipolar disorder\n* Current depressive episode\n* Current Anxiety disorder\n* Drug use during the past 6 months'}, 'identificationModule': {'nctId': 'NCT01798459', 'briefTitle': 'The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'officialTitle': 'A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.', 'orgStudyIdInfo': {'id': '0009-12-SHA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylphenidate', 'description': 'Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.', 'interventionNames': ['Drug: Methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is given before performing a continuous performance test.'}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'armGroupLabels': ['Methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Maya Kritchman-Lupo, MD', 'role': 'CONTACT', 'email': 'maiakr@clalit.org.il; mayakri@gmail.com', 'phone': '972-9-7478644'}], 'facility': 'Shalvata', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'centralContacts': [{'name': 'Maya Kritchman-Lupo, MD', 'role': 'CONTACT', 'email': 'maiakr@clalit.org.il; mayakri@gmail.com', 'phone': '972-9-7478644'}, {'name': 'Yuval Bloch, MD', 'role': 'CONTACT', 'email': 'yuvalbl@clalit.org.il', 'phone': '972-9-7478510'}], 'overallOfficials': [{'name': 'Maya Kritchman Lupo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shalvata Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Maya Kritchman Lupo', 'investigatorAffiliation': 'Shalvata Mental Health Center'}}}}