Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 5:34 AM
Study NCT ID:
NCT02009969
Status:
UNKNOWN
Last Update Posted:
2015-12-14
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial Comparisons of Abdominal and Neurological MRI Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal distribution of visceral fat versus subcutaneous fat', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'Change over time in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI)'}, {'measure': 'Changes in total brain volume', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'Change over time in total brain volume as measured by automated segmentation of a magnetic resonance image (MRI).'}, {'measure': 'Changes in grey matter volume in the brain', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'Change over time in amounts of brain grey matter as measured by automated segmentation of a magnetic resonance image (MRI).'}, {'measure': 'Changes in white matter volume in the brain', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'Change over time in amounts of brain white matter as measured by automated segmentation of a magnetic resonance image (MRI).'}, {'measure': 'Changes in the volume of brain structures', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'Change over time in the volume of brain structures as measured by automated segmentation of a magnetic resonance image (MRI).'}], 'secondaryOutcomes': [{'measure': 'Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity', 'timeFrame': 'Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge', 'description': 'To determine if an association exists between abdominal fat accumulation/distribution and psychosis symptom severity, as measured by the amounts of visceral and subcutaneous fat by automated segmentation of a magnetic resonance image (MRI) and standardized symptom rating scales, cognitive tests, and other neuropsychological examinations, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Adverse effects', 'Symptom Severity', 'Magnetic Resonance Imaging'], 'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare abdominal weight gain and fat distribution to changes in brain morphology in people taking antipsychotic medications.', 'detailedDescription': 'Abdominal weight gain is a significant side effect of antipsychotic medications. It has even been suggested to be part of the pathology of severe mental illnesses. Studies have shown that in persons with bipolar disorder, increased body mass index (BMI) is associated with irregular changes in the brain. This association has not been tested in persons with psychosis. In this study, we will be measuring abdominal fat distribution as measured by MRI to see if this is associated with abnormal brain morphology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have recently been seen at the BC (British Columbia) Psychosis Program at the University of British Columbia hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be admitted to the BC (British Columbia) Psychosis Program at UBC (University of British Columbia) Hospital\n* Must have clinically diagnosed psychosis (e.g. schizophrenia)\n* Must be fluent in English\n* Must not be contraindicated for MRI (i.e., must not be claustrophobic, have metal in the body, be pregnant, have BMI greater than or equal to 40, etc.)\n\nExclusion Criteria:\n\n• None, other than those listed above'}, 'identificationModule': {'nctId': 'NCT02009969', 'acronym': 'SCANMRI', 'briefTitle': 'Serial Comparisons of Abdominal and Neurological MRI Scans', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Serial Comparisons of Abdominal and Neurological MRI Scans of Patients With Refractory Psychosis Disorders', 'orgStudyIdInfo': {'id': 'H13-01685'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Heidi N Boyda, Ph.D.', 'role': 'CONTACT', 'email': 'hnboyda@gmail.com', 'phone': '604-875-2000', 'phoneExt': '6484'}, {'name': 'Delrae Fawcett, M.Sc.', 'role': 'CONTACT', 'email': 'delrae.fawcett@ubc.ca', 'phone': '604-875-2000', 'phoneExt': '6115'}, {'name': 'Alasdair M Barr, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BC Mental Health & Addictions Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Heidi N Boyda, Ph.D.', 'role': 'CONTACT', 'email': 'hnboyda@gmail.com', 'phone': '604-875-2000', 'phoneExt': '6484'}, {'name': 'Delrae Fawcett, M.Sc.', 'role': 'CONTACT', 'email': 'delrae.fawcett@ubc.ca', 'phone': '604-875-2000', 'phoneExt': '6115'}], 'overallOfficials': [{'name': 'Alasdair M Barr, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}