Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT00216918
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropsychological Functioning 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'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2007-01-24', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2007-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.'}], 'secondaryOutcomes': [{'measure': 'Assess changes in executive function and attention;Compare changes in neuropsychological status in a normal control group, gender and age matched to atomoxetine-treated patients at baseline and 6 months'}, {'measure': 'Efficacy of atomoxetine after 2 and 6 months, or endpoint from baseline;Assess the correlation of change from baseline to 6 months, or at study discontinuation, in ADHD symptoms with change from baseline in the neuropsychological functioning'}, {'measure': 'Assess the relationships of change from baseline to approximately 2 and 6 months, or endpoint in the core symptoms of ADHD with the changes in functional outcomes as assessed by the WFIRS-P'}, {'measure': "Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change."}]}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '21569378', 'type': 'DERIVED', 'citation': 'Dickson RA, Maki E, Gibbins C, Gutkin SW, Turgay A, Weiss MD. Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Child Adolesc Psychiatry Ment Health. 2011 May 11;5:14. doi: 10.1186/1753-2000-5-14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "A) Patients:\n\nInclusion Criteria:\n\n1. Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.\n2. Patients must have moderately severe symptoms of ADHD.\n3. Patients must be able to swallow study drug capsules.\n\nExclusion Criteria:\n\n1. Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.\n2. Patients must not be home-schooled.\n\nB) Controls:\n\nSubjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.\n\nInclusion Criteria:\n\n1\\) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder\n\nExclusion Criteria:\n\n1\\) Subjects must not be home-schooled."}, 'identificationModule': {'nctId': 'NCT00216918', 'briefTitle': 'Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-Label Pilot Study of Atomoxetine Hydrochloride to Evaluate Neuropsychological Function in Children Ages 6 to 10 Years With Attention-Deficit/Hyperactivity Disorder.', 'orgStudyIdInfo': {'id': '9721'}, 'secondaryIdInfos': [{'id': 'B4Z-CA-S013'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Atomoxetine Hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1R 2W8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}