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Dexamethasone as an Immediate Intervention

NCT ID: NCT02753166

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-12

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma

Keywords

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PTSD (Post Traumatic Stress Disorder) Emergency Department

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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DEX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isaac Galatzer-Levy, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-01318

Identifier Type: -

Identifier Source: org_study_id