Dexamethasone as an Immediate Intervention

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Trauma
• Intervention / Treatment: Drug: Dexamethasone

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Dexamethasone	Drug: Dexamethasone; 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.; Other Names: DEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)	Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test.	1 month, 3 months, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol Levels measured from saliva samples		24 hours post ED departure
Score on Subjective Units of Distress (SUDS)	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.	1 month, 3 months, 6 months, 9 months, and 12 months
Score on the Kessler 6 Scale	Measure of Psychological distress in the anxiety-depression spectrum	1 month, 3 months, 6 months, 9 months, and 12 months
Score on Life Satisfaction Scale	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.	1 month, 3 months, 6 months, 9 months, and 12 months
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Isaac Galatzer-Levy, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 12, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Emergency Department; PTSD (Post Traumatic Stress Disorder)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 15-01318