Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT03380260
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Neural Processing of Social Stimuli
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting cerebral blood flow (CBF)', 'timeFrame': 'CBF measurements will be obtained during the study visit and will last approximately 9 minutes.', 'description': 'CBF in amygdala and related neural circuits'}], 'secondaryOutcomes': [{'measure': 'Amount of Neural Activity', 'timeFrame': 'Measurements will be obtained during the study visit and will last approximately 25 minutes.', 'description': 'Task-related activation of amygdala and related neural circuits measured with blood-oxygenation-level-dependent imaging'}, {'measure': 'Ratings of Trustworthiness', 'timeFrame': 'Data will be obtained during the study visit and will last approximately 12 minutes.', 'description': 'Behavioral perceptions of the trustworthiness of others'}, {'measure': 'Self-reported paranoid ideation', 'timeFrame': 'Data will be obtained during the study visit and will last approximately 5 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The primary goal of the present study is to test whether neural activity in brain regions associated with processing threat and social stimuli may underlie paranoid thinking.', 'detailedDescription': 'Paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well as the general population, and that is associated with significant distress and impairment. Previous research suggests that increased baseline activity of the amygdala and related neural circuits may serve as a mechanism for paranoid ideation. This exploratory study will use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of paranoid ideation to test whether increases in self-reported paranoia are accompanied by increases in resting cerebral blood flow (CBF), decreased stimulus-driven neural activity in social processing networks, and increased behavioral perceptions of untrustworthiness.\n\nParticipants will be randomly assigned to participate in a paranoia induction procedure or a control condition and will then complete neuroimaging and behavioral assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 18 and 55\n\nExclusion Criteria:\n\n* current psychiatric diagnosis\n* current use of psychotropic medications\n* history of head trauma with loss of consciousness for more than 15 minutes\n* presence of neurological or neurodegenerative disorder\n* sensory impairments that preclude assessment\n* presence of intellectual disability\n* contraindications for MRI (e.g., metallic implants or pregnancy)'}, 'identificationModule': {'nctId': 'NCT03380260', 'briefTitle': 'Investigating Neural Processing of Social Stimuli', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Dallas'}, 'officialTitle': 'Investigating Neural Processing of Social Stimuli: Investigating a Neurobehavioral Mechanism of Paranoia', 'orgStudyIdInfo': {'id': '17-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paranoia Induction', 'description': 'Behavioral procedure involving social exclusion and negative feedback to induce paranoia', 'interventionNames': ['Behavioral: Paranoia Induction']}, {'type': 'NO_INTERVENTION', 'label': 'Control Condition', 'description': 'No manipulation of paranoid ideation'}], 'interventions': [{'name': 'Paranoia Induction', 'type': 'BEHAVIORAL', 'description': 'Behavioral procedure involving social exclusion and negative feedback to induce paranoia', 'armGroupLabels': ['Paranoia Induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Research Imaging Center, The University of Texas Southwestern Medical School', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Amy Pinkham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas at Dallas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Dallas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amy Pinkham', 'investigatorAffiliation': 'The University of Texas at Dallas'}}}}