Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 4:15 AM
Study NCT ID:
NCT05340504
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2022-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priscian@musc.edu', 'phone': '843-792-1433', 'title': 'James J. Prisciandaro, Ph.D.', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.", 'description': 'At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.', 'eventGroups': [{'id': 'EG000', 'title': 'N-Acetylcysteine', 'description': 'N-Acetylcysteine: 14 day trial of N-acetylcysteine 3g/day', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo Oral Tablet: 14 day trial of matched placebo', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Washout', 'description': 'Washout: 14 day washout period from study medications', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin Growth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetylcysteine', 'description': 'N-Acetylcysteine: 14 day trial of N-Acetylcysteine (3g/day) followed by MRI (Day 14)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 14 day trial of matched Placebo Oral Capsule followed by MRI (Day 14)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.426', 'spread': '0.341', 'groupId': 'OG000'}, {'value': '2.207', 'spread': '0.423', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of each experimental condition', 'description': 'Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy', 'unitOfMeasure': 'Institutional Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Overall number of participants analyzed includes participants who completed full study protocol (i.e. 2, 2-week medication trials and 1, 2-week washout period). Two participants have been removed from outcome measure data (1 - participant lost to follow up and did not complete placebo condition, 1 - participant's MRI data was unusable due to excessive head motion). Data from these 2 participants has been included in other portions of this study record (Adverse Events, Demographics, etc)."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule', 'description': 'Two, 2-week conditions.\n\nWeek 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).\n\nN-Acetylcysteine: 14 day trial of 3g NAC.\n\nWeek 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), and MRI (Day 14).\n\nPlacebo Oral Capsule: 14 day trial of matched placebo.'}, {'id': 'FG001', 'title': 'Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine', 'description': 'Two, 2-week conditions.\n\nWeek 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).\n\nPlacebo Oral Capsule: 14 day trial of matched placebo.\n\nWeek 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), and MRI (Day 14).\n\nN-Acetylcysteine: 14 day trial of 3g NAC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule', 'description': 'Two, 2-week conditions.\n\nWeek 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).\n\nN-Acetylcysteine: 14 day trial of 3g NAC.\n\nWeek 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), and MRI (Day 14).\n\nPlacebo Oral Capsule: 14 day trial of matched placebo.'}, {'id': 'BG001', 'title': 'Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine', 'description': 'Two, 2-week conditions.\n\nWeek 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).\n\nPlacebo Oral Capsule: 14 day trial of matched placebo.\n\nWeek 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), and MRI (Day 14).\n\nN-Acetylcysteine: 14 day trial of 3g NAC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '55'}, {'value': '41.33', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '60'}, {'value': '37.92', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-15', 'size': 605025, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-29T16:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2022-04-15', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-30', 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy', 'timeFrame': 'Day 14 of each experimental condition', 'description': 'Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder']}, 'descriptionModule': {'briefSummary': 'This research study evaluates the effects of anFDA-approved medication NAC in individuals with Bipolar Disorder. Participants in the study will will be assigned to two medication conditions and will take both NAC and a matched placebo. The order in which they take each medication will be random. Study medication will be taken for 14 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18-60 years\n2. Meet DSM-5 criteria for bipolar I or II disorder\n3. Able to provide informed consent and read, understand, and accurately complete assessment instruments\n4. Willing to commit to medication treatment and follow-up assessments\n5. Meets DSM-5 criteria for any mood episode (i.e., Major Depressive, Hypomanic, Manic), Current or In Partial Remission\n6. Prescribed daily use of at least one FDA-approved mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic)\n7. Willing to abstain from antioxidant supplements (e.g., coenzyme Q-10, vitamin E) for the duration of the study.\n\nExclusion Criteria:\n\n1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)\n2. Meet DSM-5 criteria for substance use disorder (other than Tobacco Use Disorder) within the past 6 months.\n3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study\n4. Any history of brain injury with loss of consciousness greater than 5 minutes\n5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)\n6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant\n7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range\n8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range\n9. Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be hazardous if taken with N-Acetylcysteine (NAC).\n10. Medication dose changes of ≥ 20% ≤ 2 weeks prior to testing\n11. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception\n12. Current suicidal or homicidal risk\n13. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale\n14. Has taken NAC in the last month or experienced adverse effects/allergic reaction from it at any time\n15. Significant claustrophobia and/or past negative experiences with MRI\n16. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)'}, 'identificationModule': {'nctId': 'NCT05340504', 'briefTitle': 'Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder', 'orgStudyIdInfo': {'id': '00117736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule', 'description': 'Group A will receive NAC 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive Placebo Oral Capsule 2 times a day for 14 days and have another MRI exam on day 14.', 'interventionNames': ['Drug: N-Acetyl cysteine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine', 'description': 'Group A will receive Placebo Oral Capsule 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive NAC 2 times a day for 14 days and have another MRI exam on day 14.', 'interventionNames': ['Drug: N-Acetyl cysteine', 'Drug: Placebo']}], 'interventions': [{'name': 'N-Acetyl cysteine', 'type': 'DRUG', 'description': 'Group A and Group B will receive N-Acetylcysteine (NAC). Group A will receive NAC as their first 14 day condition and Group B will receive NAC as their second 14 day condition. Participants will take NAC for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).', 'armGroupLabels': ['Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule', 'Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Group A and Group B will receive Placebo. Group A will receive Placebo as their first 14 day condition and Group B will receive Placebo as their second 14 day condition. Participants will take Placebo Oral Capsule for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).', 'armGroupLabels': ['Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule', 'Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University Of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'James Prisciandaro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Milken Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'James J. Prisciandaro', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}