Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00391235
Status:
COMPLETED
Last Update Posted:
2010-12-06
First Post:
2006-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
White Matter in Pediatric Bipolar Disorder: A DTI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2006-10-19', 'studyFirstSubmitQcDate': '2006-10-19', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional anisotropy in brain white matter', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bipolar disorder', 'magnetic resonance imaging', 'white matter', 'diffusion tensor imaging', 'children', 'adolescents'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cha.harvard.edu/ccad/index.shtml', 'label': 'Description of this research program at Cambridge Health Alliance'}]}, 'descriptionModule': {'briefSummary': 'Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.', 'detailedDescription': 'We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bipolar Disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6 to 13\n* Male or female\n* Right-handed\n\nExclusion Criteria:\n\n* IQ less than 70\n* Learning disabilities\n* History of autism, schizophrenia, anorexia or bulimia nervosa\n* Substance abuse\n* Claustrophobia\n* Metal in body\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00391235', 'briefTitle': 'White Matter in Pediatric Bipolar Disorder: A DTI Study', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge Health Alliance'}, 'officialTitle': 'White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study', 'orgStudyIdInfo': {'id': 'CHA-IRB-0132/09/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPD', 'description': 'Children with bipolar disorder'}, {'label': 'HC', 'description': 'Healthy comparison children'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02155', 'city': 'Medford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cambridge Health Alliance', 'geoPoint': {'lat': 42.41843, 'lon': -71.10616}}], 'overallOfficials': [{'name': 'Jean A Frazier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge Health Alliance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge Health Alliance', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Child Adolescent Psychiatry.', 'class': 'OTHER'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jean Frazier, MD', 'oldOrganization': 'Cambridge Health Alliance'}}}}