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Corticosteroid

2 for Post-Traumatic Stress Disorder

N/A
Waitlist Available
Led By Doulas L Delahanty, PhD
Research Sponsored by Kent State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
involved in a traumatic event and admitted to the level 1 trauma center within 12 hours after the trauma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one- and three-months post-trauma
Awards & highlights

Study Summary

People experience a wide range of outcomes following a traumatic event. Although rates differ depending on type of trauma, 20-60% of trauma victims may develop posttraumatic stress disorder (PTSD). However, not all trauma victims develop PTSD. Previous research has found that trauma victims who develop PTSD excrete lower levels of urinary cortisol immediately after a trauma than victims who do not develop PTSD. Other research has suggested that increasing levels of cortisol may protect against the development of PTSD in patients such as yourself- but this has not yet been examined. Cortisol is a naturally occurring hormone in your body, and the present study is designed to test whether increasing cortisol levels can protect against or decrease symptoms of PTSD. Participants in this study will be randomly assigned to one of two treatment groups. Participants will receive either hydrocortisone (20mg, twice per day) or a placebo (a sugar pill) for 10 days with a six-day taper. There is an equal chance of being in either treatment group, and neither the participant nor the experimenters will know which treatment was received (except in case of an emergency).

Eligible Conditions
  • Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one- and three-months post-trauma
This trial's timeline: 3 weeks for screening, Varies for treatment, and one- and three-months post-trauma for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered PTSD Scale (CAPS)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 2Active Control1 Intervention
oral pill of hydrocortisone (ranging from 20mg - 2.5mg) taken for 10 days with a taper for 6 days (based on Pitman et al, 2002).
Group II: 1Placebo Group1 Intervention
receipt of a placebo pill for 16 days

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,084 Total Patients Enrolled
Kent State UniversityLead Sponsor
41 Previous Clinical Trials
6,528 Total Patients Enrolled
Doulas L Delahanty, PhDPrincipal InvestigatorKent State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025