Dexamethasone as an Immediate Intervention

NCT02753166 | Withdrawn Phase 1

• 1 other identifier: 15-01318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

PTSD (Post Traumatic Stress Disorder); Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Score on Center for Epidemiologic Studies Depression Scale (CES-D)

  1 month, 3 months, 6 months, 9 months, and 12 months

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Control

NO INTERVENTION

Interventions

Dexamethasone DRUG

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.

Also known as: DEX

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Combat Disorders; Emergencies

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Isaac Galatzer-Levy, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 27, 2016
• Study Start: January 1, 2017
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

US (1)