Clinical trial NCT02753166: Dexamethasone as an Immediate Intervention
Official title: Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Trauma
Keywords: PTSD (Post Traumatic Stress Disorder)
Emergency Department
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* . 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.
* Self-reported adverse reactions to steroids

Primary outcomes:
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
Secondary outcomes:
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
measure: Score on the Kessler 6 Scale
timeFrame: 1 month, 3 months, 6 months, 9 months, and 12 months
measure: Score on Life Satisfaction Scale
timeFrame: 1 month, 3 months, 6 months, 9 months, and 12 months
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
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Isaac Galatzer-Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: