Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-26 @ 7:02 PM
Study NCT ID:
NCT00104195
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2005-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001010', 'term': 'Anxiety, Separation'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-15', 'studyFirstSubmitDate': '2005-02-23', 'studyFirstSubmitQcDate': '2005-02-23', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intolerance of Uncertainty', 'timeFrame': 'at time of assessment/enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Adolescence', 'Generalized Anxiety Disorder'], 'conditions': ['Anxiety Disorders', 'Separation Anxiety Disorder', 'Phobic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study how teens with and without an anxiety disorder make decisions.\n\nThis is a brain imaging study using functional magnetic resonance imaging (fMRI) in adolescents between the ages of 13 and 17.', 'detailedDescription': 'Preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. However, behavioral ratings of certainty during the task showed differences between groups. Anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p \\< .05). This difference was consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks showed that subjects responded as expected. Reaction times (RT) during uncertain conditions of the HiLo-Game were significantly longer than during more certain conditions (p = .001). Diary Task RTs for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p \\< .05). Preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary results were not submitted for publication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anxious and healthy adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must meet diagnostic criteria for Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia, OR must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls)\n* Sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history\n\nExclusion Criteria:\n\n* Having any major medical conditions that may interfere with interpretation of results or be associated with risk in an MRI environment (history of metal implants, or contraindications to MRI scanning for research purposes, including pregnancy)\n* Current evidence of Autism, Major Depression, Substance Abuse, Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Panic Disorder, Tic Disorders, significant suicidality, lifetime history of psychosis or mania.\n* Estimated Full-Scale IQ below 80\n* Inability or unwillingness to remain still during scanning\n* Inability or unwillingness to provide assent\n* Absence of signed consent by parent or legal guardian\n* Current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing Department of Social Services (DSS) involvement'}, 'identificationModule': {'nctId': 'NCT00104195', 'briefTitle': 'A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth', 'orgStudyIdInfo': {'id': 'H11610'}}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "New York University's Child Study Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'F. Xavier Castellanos', 'investigatorAffiliation': 'NYU Langone Health'}}}}