Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT02753166
Status:
WITHDRAWN
Last Update Posted:
2017-12-14
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone as an Immediate Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-12', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test.'}], 'secondaryOutcomes': [{'measure': 'Cortisol Levels measured from saliva samples', 'timeFrame': '24 hours post ED departure'}, {'measure': 'Score on Subjective Units of Distress (SUDS)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'Scale of 0 to 10 for measuring the subjective intensity of disturbance or distress currently experienced by an individual. The individual self assesses where they are on the scale.'}, {'measure': 'Score on the Kessler 6 Scale', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'Measure of Psychological distress in the anxiety-depression spectrum'}, {'measure': 'Score on Life Satisfaction Scale', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months', 'description': "The Satisfaction with Life Scale to assess satisfaction with people's lives as a whole. The scale does not assess satisfaction with specific life domains, such as health or finances, but allows subjects to integrate and weigh these domains in whatever way they choose."}, {'measure': 'Score on Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months'}, {'measure': 'Score on Perceived Ability to Cope with Trauma Scale (PACT)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD (Post Traumatic Stress Disorder)', 'Emergency Department'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18-70 years\n* Evidence of acute Post Traumatic Event (PTE) exposure defined by Diagnostic and Statistical Manual criterion 'A'\n* Evidence of a significant stress response defined by DSM V PTSD criterion 'B' and meeting at least criteria for 'partial PTSD' or a minimum of 3 of 4 DSM V PTSD symptom criterion\n* Score of 60 or higher on the Subjective Units of Distress Scale (SUDS)\n* Living in New York tri-state area\n* Fluency in English, Spanish\n\nExclusion Criteria:\n\n* Admission to an intensive care unit or other overnight admission\n* In the Emergency Department for more than 6 hours\n* Evidence of ongoing traumatic exposure (e.g. domestic violence)\n* Evidence of psychotic symptoms\n* Evidence of homicidality/suicidality\n* Adults with an open head injury, a positive CT scan, loss of consciousness \\>30 seconds or survivors in a coma\n* Adults in police custody or Department of Correction (DOC) patients\n* Inability to understand the study's procedures, risks, or side effects, or otherwise unable to give informed consent.\n* Females who are nursing or pregnant (as confirmed by a positive urine pregnancy test).\n* Permanent cardiac pacer implant.\n* . Self-reported medical conditions that may be affected by DEX including asthma, epilepsy,diabetes, liver disease, kidney disease, thyroid disorder, muscle disorder, history of malaria,tuberculosis, osteoporosis, glaucoma or cataracts.\n* Self-reported adverse reactions to steroids"}, 'identificationModule': {'nctId': 'NCT02753166', 'briefTitle': 'Dexamethasone as an Immediate Intervention', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses', 'orgStudyIdInfo': {'id': '15-01318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['DEX'], 'description': 'After six (6) hours of the accident, subject will take 5 mg of DEX in the Emergency Department (ED). Within twenty-four (24) hours, the subjects will send in a saliva sample. After sexen (7) days, subjects will participate in a phone interview. After thirty (30) days, subjects will participate in an online assessment and return for a one month follow-up visit. Subjects will then participate in online assessments at months 3,6,9, and 12 months.', 'armGroupLabels': ['Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Isaac Galatzer-Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}