Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses

NYU Langone Health1 site in 1 countryJanuary 2017

ConditionsTrauma

InterventionsDexamethasone

DrugsDexamethasone

Overview

Phase: Phase 1
Intervention: Dexamethasone
Conditions: Trauma
Sponsor: NYU Langone Health
Locations: 1
Primary Endpoint: Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

December 12, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults 18-70 years
•Evidence of acute Post Traumatic Event (PTE) exposure defined by Diagnostic and Statistical Manual criterion 'A'
•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
•Score of 60 or higher on the Subjective Units of Distress Scale (SUDS)
•Living in New York tri-state area
•Fluency in English, Spanish

Exclusion Criteria

•Admission to an intensive care unit or other overnight admission
•In the Emergency Department for more than 6 hours
•Evidence of ongoing traumatic exposure (e.g. domestic violence)
•Evidence of psychotic symptoms
•Evidence of homicidality/suicidality
•Adults with an open head injury, a positive CT scan, loss of consciousness \>30 seconds or survivors in a coma
•Adults in police custody or Department of Correction (DOC) patients
•Inability to understand the study's procedures, risks, or side effects, or otherwise unable to give informed consent.
•Females who are nursing or pregnant (as confirmed by a positive urine pregnancy test).
•Permanent cardiac pacer implant.

Arms & Interventions

Dexamethasone

Intervention: Dexamethasone

Outcomes

Primary Outcomes

Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)

Time Frame: 1 month, 3 months, 6 months, 9 months, and 12 months

Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test.

Secondary Outcomes

Score on Center for Epidemiologic Studies Depression Scale (CES-D)(1 month, 3 months, 6 months, 9 months, and 12 months)
Score on Perceived Ability to Cope with Trauma Scale (PACT)(1 month, 3 months, 6 months, 9 months, and 12 months)
Cortisol Levels measured from saliva samples(24 hours post ED departure)
Score on Subjective Units of Distress (SUDS)(1 month, 3 months, 6 months, 9 months, and 12 months)
Score on the Kessler 6 Scale(1 month, 3 months, 6 months, 9 months, and 12 months)
Score on Life Satisfaction Scale(1 month, 3 months, 6 months, 9 months, and 12 months)